08-23-2010: Conducting Bulletproof CAPA Investigations – ADVANCED

Build New CAPA Investigation Techniques to Meet Tougher FDA Demands in 2010
Presented by FDAnews & Immel Resources
ept 29-30 2010 -- San Juan PR USA
http://www.CAPAworkshop.com

Falls Church VA USA -- Medical E-Mail News™ / Aug 23 2010 — During Sept 29-30 2010, FDAnews and Immel Resources are presenting an important new workshop in San Juan PR USA: Conducting Bulletproof CAPA Investigations — ADVANCED; a program to assist companies in building new CAPA investigation techniques to meet tougher FDA Demands in 2010.

FOCUS:

The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important.
But creating an FDA-proof CAPA (corrective and preventive action) has never been easy.

If only you could pick the brain of someone who is coping successfully with CAPA -- the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can.

FDAnews and Immel Resources are presenting an advanced version of their previous CAPA investigations class -- designed to meet tough FDA scrutiny in 2010.

IN THIS ADVANCED, INTERACTIVE WORKSHOP YOU WILL:

Learn how to respond to the FDA and implement effective CAPA to prevent regulatory action and get a closeout letter
Receive an insider view of the FDA's own training program for investigators -- portions of the Reid Technique DVD will be reviewed during the course
Review lessons learned from nine years of FDA warning letter citations on CAPA investigations
Learn key problem-solving techniques to break down a problem into its component parts: CIA, Kepner-Tregoe and FMEA
Receive a course workbook complete with charts, forms, manuals and guidance
Interact with colleagues to participate in 14 interactive exercises

ADDITIONAL WORKSHOP BENEFITS INCLUDE:

Gain valuable strategies for performing in-depth interviews and determining individuals responsible for an event
Using proven law enforcement techniques, discover best practices for training, assigning and managing your lead investigators
Benchmark current best practices in CAPA and investigations with your peers
Learn 22 great investigative tools you can teach to all your employees
Obtain sample forms for conducting investigations and case reviews
Review required FDA notifications, such as field alerts, medical device reports, biologic product deviation reports, adverse events, serious adverse events, recalls, corrections and removals
Understand the four elements of a well-written report and how to coach employees on report writing

REGISTER NOW:

Conducting Bulletproof CAPA Investigations -- Advanced:
Interactive Workshop on Investigating Techniques to Meet Regulatory Scrutiny
http://www.capaworkshop.com


MEET YOUR INSTRUCTOR:

Barbara K. Immel, a published author and nationally known speaker, is president of Immel Resources LLC and editor of the Immel Report.™ She has 26 years of industry experience working in corporate quality assurance, compliance, training, documentation, and labeling. Barb’s experience includes more than 12 years with Syva Company, Chiron Corporation, and Syntex Corporation. Barb is the chairperson of the annual FDA Inspections Summit hosted by FDAnews.

Barb has presented at hundreds of national and international industry meetings, and has taught well-respected GMP classes for more than 20 years. She has created and taught biotechnology and drug development courses for UC Berkeley Extension, served as an instructor for the Pharmaceutical and Biotechnology Quality Assurance Course for the University of Wisconsin at Madison, served as a panelist at the Stanford Professional Publishing Course, and taught the tutorial on FDA’s Phase 1 proposals at the International GMP Conference at the University of Georgia. Barb has been teaching well-respected courses on writing reports for deviations and failure investigations, and on conducting CAPA investigations, for the past 8 years (2000-2008).

WHO WILL BENEFIT:

CAPA managers
Compliance officers
Training managers
GCP, GLP and GMP professionals
QA/QC managers and directors
Quality engineers
Regulatory affairs managers
Anyone wishing to improve an organization’s CAPA activities and investigations

Your valuable course materials book is packed with tools and reference materials you can put to use right away, including:

FMEA chart
How to respond to FDA Form 483s and warning letters
Comprehensive CAPA bibliography and recommended reading list
Current FDA regulations
Pertinent guidance documents
Three articles on problem investigations
FDA inspection manuals
FDA's out-of-specification guidance
ICH E6 good clinical practice guidance
Recent FDA Form 483s or EIRs
Pertinent FDA warning letters
16 great interviewing tips
Two articles on CAPA
FDA field alert, MDR, BPDR, AE forms
FDA recall guidance
Writing an executive summary
Fishbone cause and effect diagrams
Tips on documenting/presenting root causes
Preventive action flowchart
Sample interview forms
Sample audit "checklists"
Writer's questionnaire
Speaker's questionnaire
On customer complaints
CAPA checklist
Mock failure investigation reports
Sample investigation plan
Sample case review form
Tips on conducting out-of-specification investigations
Compliance tips/best practices

READ WHAT PAST ATTENDEES HAVE TO SAY:

“Very thorough. Great real-life experiences. Enjoyed this course, the content and especially Barbara. Her wealth of knowledge and presentation style welcomes all levels of personnel in an engaging environment.”
-- Charla Lee, Supervisor, Incident Team, Talecris Biotherapeutics

“Very, very knowledgeable in what she is teaching. Excellent presence. I liked the group work and the interactions with others and their experiences.”
-- Jason Ferens, Quality Engineer, Fort Wayne Metals

“Barbara was very knowledgeable. The way the class was structured with the interactive exercises, videos, etc. made the days go fast. I got a lot of useful information to bring back to my company. Talking to peers gave insight into other company’s processes.”
-- Loren Jennings, Quality Systems Coordinator, Fujirebio Diagnostics

CONFERENCE DETAILS:

Conducting Bulletproof CAPA Investigations -- ADVANCED
Sept 29-30 2010 -- San Juan PR USA
Conrad San Juan Condado Plaza Hotel

TUITION: $1,897 per attendee

TO REGISTER:

Online: http://www.CAPAworkshop.com
Fax: 703-538-7676
Mail to: FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431

PROGRAM GUARANTEE:

You must be fully satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.

CANCELLATIONS/SUBSTITUTIONS:

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted -- nor refunds issued -- within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

TEAM DISCOUNTS:

Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call 703-538-7600 for details.

ABOUT FDANEWS:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Source: FDAnews

top

08-20-2010: Assessing the Potential for Allergic Contact Dermatitis Workshop Set
 
Jan 20 2011 -- NIH Natcher Conference Center, Bethesda MD USA
http://iccvam.niehs.nih.gov/meetings/Implement-2011/ImplmtnWksp.htm


Bethesda MD USA-- Medical E-Mail News™ / Aug 20 2010 -- The US National Institute of Environmental Health Sciences announced today it is holding an important workshop on Jan 20 2011, on methods for evaluating the potential for allergic contact dermatitis.

Focus:

Officials want to help the medical industry develop a practical understanding of the theory and application of available alternative methods for evaluating hazard potential of chemicals and products that can also minimize animal use, and avoid pain and distress.

Registration:

The workshop is open to the public with no attendance fee, but attendees must register in advance:
http://iccvam.niehs.nih.gov/contact/reg-form-Implement.htm

Who Should Attend:

Scientists, professionals and executives from industry, government and academia, who want to learn more about available alternative test methods for assessing allergic contact dermatitis hazards.

Goals:

Provide an overview of the available methods in each area, including the applications, strengths and weaknesses of each method
Provide information on the procedures for conducting and interpreting data in accordance with regulatory testing requirements and guidelines
Allow an opportunity to become familiar with data generated by each test method
Provide a forum for scientists to share information on the appropriate use of results in regulatory safety testing
Discuss challenges of incorporating alternative test methods into regulatory safety testing guidelines
Identify and discuss new methods in the development and validation pipeline for each safety testing area,
Identify ways to increase the availability of high quality data necessary for validating new methods

Source: US National Institute of Environmental Health Sciences



top

08-18-2010: Australia Implants 1st SynCardia Total Artificial Heart

St. Vincent's Hospital Implants Australia’s 1st SynCardia Total Artificial Heart
Sydney Hospital to Serve as SynCardia’s Regional Certification Center for Asia-Pacific
http://www.syncardia.com


Tucson AZ USA -- Medical E-Mail News™ / Aug 18 2010 -- On Aug. 5, St. Vincent’s Hospital in Sydney performed Australia’s first implant of the SynCardia temporary Total Artificial Heart. The patient, a 50-year-old-male suffering from total heart failure, is the first recipient of the Total Artificial Heart in the Southern Hemisphere. The surgery was performed by heart surgeons Drs. Phillip Spratt and Paul Jansz.
View extensive Media Coverage.

“At any one time there can be around 30 people waiting for a heart transplant at our hospital,” said Dr. Spratt, Head of the St. Vincent’s Hospital Heart/Lung Transplant Unit. “We selected this patient to receive the Total Artificial Heart as a bridge-to-transplant because without it, he would have had less than two weeks to live.”

Angelo Tigano had suffered from idiopathic cardiomyopathy for more than a decade. Walking more than a few steps left him gasping for breath, until finally he was unable to eat or sleep. Mr. Tigano says he hopes the Total Artificial Heart will improve his quality of life and allow him to return to some of the normal activities he did before suffering heart failure.

“The Total Artificial Heart has no equal,” said Dr. Spratt, who led the Total Artificial Heart implant surgery. “Unlike a left ventricular assist device (LVAD), which helps the failing left ventricle, the Total Artificial Heart replaces both the left and right heart ventricles which are responsible for pumping blood.”

The implant surgery was proctored by world-renowned heart surgeon Dr. Jack Copeland, who recently joined the faculty at the University of California, San Diego, and has performed more than 100 implants of the Total Artificial Heart. St. Vincent’s Hospital is the 31st hospital in the world to become SynCardia Certified Center. Currently, there are Certified Centers in the U.S., Canada, France, Germany, Italy, Sweden, Austria, Russia and now Australia.

St. Vincent’s is the largest transplant hospital in Australia and will serve as SynCardia’s Regional Certification Center for the Asia-Pacific.Device Technologies is the Australasian distributor of the SynCardia Total Artificial Heart and is a major supplier of leading edge medical equipment and consumables to hospitals and healthcare professionals throughout Australia and New Zealand.

Cardiovascular disease is the leading cause of death in Australia. Despite the increase in this condition and consequent growing demand for transplants, the supply of donor hearts is falling in Australia. In 2009, a total of 60 heart transplants took place, compared with 82 in 2008. Australia has one of the lowest donation rates in the developed world with only 12 donors per million in 2008.
Source: http://www.donatelife.gov.au/Discover/Facts-and-Statistics.htm

About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

Sign-up to receive the latest news updates from SynCardia
For additional information, please visit: http://www.syncardia.com


Source: SynCardia Systems Inc



top

08-16-2010: Clinical Quality Assurance: Roles & Responsibilities for Auditors & Managers

Clinical Quality Assurance: Roles & Responsibilities for Auditors & Managers
Presented by MSceppa Consulting & FDAnews; Sept 15-16 2010; Raleigh NC USA
http://www.CQAworkshop.com


Falls Church VA USA -- Medical E-Mail News™ / Aug 16 2010 — Medical industry professionals and executives are invited to attend a new program -- Clinical Quality Assurance Workshop: Roles & Responsibilities for Auditors & Managers -- on Sept 15-16 2010 in Raleigh NC. It is being presented by MSceppa Consulting and FDAnews.

Now you can learn how to FDA-proof your CQA audits, eliminate costly mistakes and avoid FDA warning letters that say: "You failed to obtain and document that valid informed consent was obtained for each of the subjects enrolled in the study as required by stated regulations."

WHAT:

Clinical trial sponsors rely on clinical quality assurance (CQA) auditors to find vulnerabilities before noncompliance can shut down their studies. But with millions of dollars and decades of research at stake, study staffers aren't always eager to cooperate.

That's why even the most experienced CQA auditors must apply the necessary tools and skills to the CQA function, including how to:

Understand the basic principles of GCPs and international regulations
Determine if GCPs are being followed and what needs to be documented
Balance the relationships -- QA, clinical and the CRO -- in the ever-changing economy where clinical study
outsourcing is common
Define responsibilities with outsourced clinical trials and the role communication plays in maintaining compliance
Select sites to be audited -- strategies for deciding who to audit
Audit a CRO or central lab -- who and how do you audit these specialized providers
Manage the audits (logistics, time, etc.) -- understanding management of the audit is essential to
assuring completion of everything that needs to be done
Conduct the audits -- what do you do and what interviewing skills are needed
Compose the site visit audit report -- writing it is sometimes the hardest thing to accomplish
Evaluate the audit findings and implementing corrective actions -- once the report is written the audit is not over
Master FDA inspections and avoid the top five GCP violations
Click here to register

WHO WILL BENEFIT:

Clinical quality assurance managers and auditors
Clinical site directors
Clinical research associates/coordinators
Regulatory affairs
IRB administrators

MEET YOUR INSTRUCTOR:

Michelle Sceppa, Principal/Founder of MSceppa Consulting, has more than 25 years of experience in quality assurance and regulatory compliance in the pharmaceutical and medical device industries. As a lead auditor, she has conducted and managed more than 300 internal and external audits for drug, biologic and medical device firms in the US and Europe.

Ms. Sceppa has implemented and managed preclinical, clinical and manufacturing quality assurance programs for numerous clients, and has knowledge in the details of compliance with all U.S. federal regulations, including: good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP) for drugs, biologics and medical devices.

Ms. Sceppa is also certified in the Q7A regulations for the manufacture of active pharmaceutical ingredients. Since 2002, she has been a faculty member of the Parenteral Drug Association's (PDA) Training & Research Institute (PDA-TRI) in Baltimore MD.

CONFERENCE DETAILS:

Clinical Quality Assurance: Roles & Responsibilities for Auditors & Managers
Sept 15-16 2010; Raleigh NC USA

TUITION:

$1,797 per attendee

TO REGISTER:

Online: http://www.CQAworkshop.com

Fax: 703-538-7676

Mail to:
FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431


PROGRAM GUARANTEE:

You must be entirely satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.

CANCELLATIONS/SUBSTITUTIONS:

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted -- nor refunds issued -- within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

TEAM DISCOUNTS:

Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call 703-538-7600 for details.

ABOUT FDANEWS:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Source: FDAnews



top

08-12-2010: National Forum on Quality Improvement in Health Care

Institute for Healthcare Improvement (IHI) to Host 22nd Annual National Forum on Quality Improvement in Health Care
Dec 5-8, 2010 -- Orlando, FL, USA
http://www.IHI.org/Forum

Cambridge MA USA -- Medical E-Mail News™ / Aug 12, 2010 — IHI's 22nd Annual National Forum on Quality Improvement in Health Care, a conference that brings together health care professionals and students dedicated to providing safe, effective patient care at a reasonable cost, will take place in Orlando, Florida, at the Marriott World Center Resort & Convention Center, on Dec 5-8, 2010.

This year's National Forum will focus on the many ways that we all "take care," and will feature:
Over 84 workshops and six educational tracks, including: Hospital Care; Innovation and Spread; Leadership and Governance; Measurement Tools, Technology, and Quality Processes; and more
Four keynote presentations
Five special interest keynotes
28 half-day Learning Labs that offer specific "How-To" improvement information
28 full-day Minicourse Sessions that offer plenty of hands-on learning
An educational and lively Exhibition Hall
A special CEO and Leadership Summit
Quality improvement posterboards displaying organizations' success stories
Unlimited opportunities for networking
The option to earn Continuing Education credits for physicians, nurses, and pharmacists

This year's National Forum guest speakers include:

Maureen Bisognano; President and CEO, IHI
Atul Gawande, MD, MPH; General & Endocrine Surgeon, Brigham & Women's Hospital
George Halvorson;Chairman and CEO, Kaiser Permanente
Gary Kaplan, MD; CEO, Virginia Mason Medical Center
Laura Adams; President and CEO, Rhode Island Quality Institute
John Halamka, MD; Chief Information Officer, CareGroup
T.R. Reid; Author, Foreign Correspondent, & Documentary Filmmaker
Jenny Allen; Writer & Performer

For more details on the conference agenda, featured speakers, and accommodation information, please click here.



About the Institute for Healthcare Improvement:

The Institute for Healthcare Improvement (IHI) is an independent not-for-profit organization helping to lead the improvement of health care throughout the world. Founded in 1991 and based in Cambridge MA, IHI works to accelerate improvement by building the will for change, cultivating promising concepts for improving patient care, and helping health care systems put those ideas into action. We hope to see you in Orlando in December.

Source: Institute for Healthcare Improvement


top

08-11-2010: Total Artificial Heart Manufacturer Launches Industry's 1st E-Commerce Site
Total Artificial Heart Manufacturer Launches Industry's 1st E-Commerce Site
SynCardia’s Total Artificial Hearts, Drivers & Other Accessories Available 24/7 to World’s Top Transplant Centers via Shop.SynCardia.com
http://www.syncardia.com


Tucson AZ USA -- Medical E-Mail News™ / Aug 11 2010 — On August 11, SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced the launch of its new online store, http://Shop.SynCardia.com. SynCardia is the first company in the mechanical circulatory support industry to make its products available to customers through an e-commerce site 24/7.

“Shop.SynCardia.com streamlines the ordering process for our customers,” said Rodger Ford, SynCardia CEO. “The site offers all SynCardia products in one place for the surgeons, medical staff and their patients at SynCardia Certified Centers around the world. We have already processed orders through the site for Total Artificial Hearts and SynCardia Gear.”

Electronic ordering through the e-commerce site guarantees that all information is current and correct, eliminating the risk of using outdated order forms, catalogs or part numbers. When staff at SynCardia Certified Centers log in, they will see each product, including the price, a photo and a description. After the order has been placed, http://Shop.SynCardia.com will send customers confirmation emails that their order has been received.

Shop.SynCardia.com offers the following products online:

Medical Equipment: Using a unique username and password to login, SynCardia Certified Centers can order Medical Equipment including Total Artificial Hearts, implant drivers for use in the operating room, Freedom™ portable drivers for patient use in the hospital and at home and other SynCardia products.
Patient Accessories: Patients can view SynCardia accessories such as additional driver batteries or a second Freedom Shoulder Bag, Backpack or Accessory Bag. Patients can then order these accessories through their SynCardia Certified Center.
SynCardia Gear: SynCardia Gear can be purchased by anyone who visits the website using a secure PayPal™ Shopping Cart. SynCardia Gear includes Team SynCardia Bike Jerseys and Bibs (cycling shorts). Team SynCardia cycling consists of friends and supporters of SynCardia with the goal of promoting cardiovascular health.

Shop.SynCardia.com serves SynCardia Certified Centers around the world, including heart hospitals in the U.S., Canada, France, Germany, Italy, Sweden, Austria, Russia and Australia.

About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

Sign-up to receive the latest news updates from SynCardia
For additional information, please visit: http://www.syncardia.com

Source: SynCardia Systems Inc


top
 

08-10-2010: CardioTec Conference To Address Opportunities & Challenges In Cardiovascular Device Manufacturing

OEM Professionals, Contract Manufacturers and Suppliers Invited to Attend
Sept 15 2010 -- Northland Inn, Minneapolis MN USA
http://www.cardiotec.com

Ramsey NJ USA -- Medical E-Mail News™ / Aug 10 2010 — CardioTec is the first and only conference dedicated to addressing the challenges facing the cardiovascular device manufacturing industry. Hosted by Medical Product Outsourcing magazine, CardioTec invites OEM professionals and contract manufacturers/suppliers to explore manufacturing issues through a specialized agenda and extraordinary lineup of speakers.

WHEN:

CardioTec will take place Sept 15 2010 at the Northland Inn in Minneapolis MN USA.
Visit http://www.cardiotec.com for more information.

WHAT:

"As a major center for cardiovascular device development and manufacturing, the Twin Cities is the ideal location for such an important event," said Liz Rammer, Executive Vice President, LifeScience Alley. "We are excited to support CardioTec and feel it adds value by providing a forum for the industry to interact and discuss issues affecting product development, research and innovation."

Participants will discuss driving innovation from research to commercialization at sessions developed by the American Heart Association, Midwest Affiliate-Twin Cities Division and the Medical Devices Center at the University of Minnesota.

SPEAKERS -- those leading the discussion on innovation to include:

Thomas Gunderson, Managing Director, Senior Analyst, Piper Jaffray
Timothy D. Henry, MD, FACC, Interventional Cardiologist, Minneapolis Heart Institute, Abbott Northwestern Hospital
Ken Liebman, Partner, Faegre & Benson
David W. Stassen, Managing Director, Split Rock Partners
Arthur G. Erdman, P.E, Director, Medical Devices Center, Univ. of Minnesota
Marie Guion Johnson, Ph.D, Director, Medical Innovation Fellows Think Tank
Joe Hofmeister, Technology Marketing Mgr, Biomedical/Medical Devices Center, Univ. of Minn, Office for Technology Commercialization

ADDITIONAL DISCUSSION PARTICIPANTS:

Representatives from ATS Medical, Boston Scientific Corp., Medtronic Inc. and St. Jude Medical Inc. will address such key issues as operational excellence, pricing pressures and the various phases of medical device development.

Shannon Crespin, VP, Global Supply Chain for CardioVascular, Medtronic Inc.
Bryan Szweda, Senior Director of Operations, St. Jude Medical Inc.
Jon Ewert, Project Manager, Boston Scientific Corp.
David R. Elizondo, VP, Research Development & Clinical Affairs, ATS Medical
Phil Ebeling, VP R&D Cardiovascular Division, St. Jude Medical Inc.

Register for CardioTec at http://www.regonline.com/Checkin.asp?EventId=820958

SPONSORS:

CardioTec is sponsored by: B Braun, Covidien plc, Creganna-Tactx Medical, Donatelle, Helix Medical LLC, Heraeus, Interface Catheter Solutions, Interplex Medical LLC, Linguanational Translations Inc., MicroLumen Inc., NDC, NDH Medical Inc., Norman Noble Inc., Phillips Plastics Corporation, ProMed Molding, Inc., SMC Ltd., Stellar Technologies, Tegra Medical, Vaupell Inc. and Vesta Inc.

About Medical Product Outsourcing Magazine:

Medical Product Outsourcing (MPO) is the only global magazine dedicated to the growing trend of medical device outsource manufacturing. In-depth coverage includes comprehensive feature articles, industry news, trends and developments pertinent to the contract manufacturer-OEM relationship. MPO examines the increasingly complex and demanding requirements of managing outsourcing partnerships. Medical Product Outsourcing is brought to you by Rodman Publishing, which also publishes Orthopedic Design & Technology, a leading source of information devoted to the highly specialized field of orthopedic product manufacturing.

Source: CardioTec

08-09-2010: Medical Device Risk Management: An Interactive Workshop
Medical Device Risk Management: An Interactive Workshop
Presented by Ombu Enterprises & FDAnews; Sept 21-22 2010; Minneapolis MN
http://www.DeviceRiskManagement.com

Falls Church VA USA -- Medical E-Mail News™ / Aug 09 2010 — Medical industry professionals and executives are invited to attend a new program -- Medical Device Risk Management: An Interactive Workshop -- to be held Sept 21-22, 2010 in Minneapolis and presented by Ombu Enterprises and FDAnews.

FOCUS:

Medical Device Risk Management. A highly complex undertaking? Very much so. Getting more difficult all the time? Yes.

One you can master with training by an expert? Absolutely.

The pressure on medical device and diagnostic firms is palpable -- especially when it comes to building, maintaining and auditing their risk management plan.

It requires the latest thinking in risk management principles, knowledge of the applicable risk assessment tools, and an understanding of the practical implications of the design, validation and manufacturing decisions that need to be made.

And now, you can discover what you need to know to start down the path of becoming a risk management expert.

TW0-DAY PROGRAM:

Register today for two days of intensive training at Medical Device Risk Management: An Interactive Workshop.

You will learn:

How to perform risk and hazard assessments as written in ISO 14971:2007
The differences between hazards, harms and risks and the unique tools to evaluate each one
How to develop a risk evaluation matrix -- assessing the probability of occurrence and the severity of harm
How to apply common tools for risk evaluation such as:

Event tree analysis (ETA)
Failure modes and effects analysis (FMEA)
Fault tree analysis (FTA)
Hazard analysis and critical control points (HACCP)
Preliminary hazard analysis (PHA)
Hazard and operability studies (HAZOP)
And much more.

WORKSHOP LEADER:

Dan O'Leary, President of Ombu Enterprises LLC, will enhance your training with case studies to illustrate the concept of risk and to examine real-life serious events in medical device manufacturing.

Plus, he'll incorporate interactive exercises, leading you through the steps from recognizing risks all the way to assuming the role of quality auditor.

REGISTER TODAY:

Who Will Benefit:

Project managers involved in design and development
Design engineers
Quality engineers
Manufacturing engineers
Quality auditors
Production managers
Scientists involved in device research and development
Medical staff evaluating risk, safety or effectiveness
Quality or regulatory staff assigned to complaint, CAPA or MDR management
Training personnel
General/corporate counsel

MEET YOUR INSTRUCTOR:

Dan O'Leary has more than 30 years experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.

He is president of Ombu Enterprises LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. O'Leary has a master's degree in mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and six sigma black belt; and is certified by APICS in resource management.

CONFERENCE DETAILS:

Medical Device Risk Management: An Interactive Workshop
Sept 21-22 2010 -- Minneapolis MN

TUITION: $1,797 per attendee

 TO REGISTER:

Online: http://www.DeviceRiskManagement.com
Fax: 703-538-7676
Mail to: FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431

PROGRAM GUARANTEE:

You must be fully satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.

CANCELLATIONS/SUBSTITUTIONS:

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted -- nor refunds issued -- within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

TEAM DISCOUNTS:

Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call 703-538-7600 for details.

ABOUT FDANEWS:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Source: FDAnews


top

08-04-2010: Insurance & Publicly Funded Programs
UC Irvine Impact of Health Care Reform on Physicians, Hospitals,
Insurance & Publicly Funded Programs
Video of May 27 2010 Distinguished Speaker Program now posted at:
http://www.merage.uci.edu/go/hcspeakers


Irvine CA USA -- Medical E-Mail News™ / Aug 4 2010 -- The UC Irvine Paul Merage School of Business at UC Irvine Center for Health Care Management & Policy announced today it has posted online its next video in its ongoing Special Presentation Speaker Program series: http://www.merage.uci.edu/go/hcspeakersvideo
The event, Impact of Health Care Reform on Physicians, Hospitals, Insurance & Publicly Funded Programs, was held at the UC Irvine campus on May 27, and moderated by Christopher De Rosa, President of CIGNA Healthcare of California. The recent passage of historic health care reform legislation impacts all sectors of the health care industry. Event speakers provided a strategic analysis on how health care reform will affect these key sectors: hospitals, physicians, insurers, and publicly funded programs.


Speakers:

Richard F. Afable MD MPH -- President & CEO, Hoag Memorial Hospital Presbyterian
Richard Chambers -- CEO, CalOptima
Jay J. Cohen MD MBA -- President & Chairman, Monarch HealthCare
Tammy Tucker -- VP, Anthem Blue Cross

About the Health Care Speaker Series:

The Special Presentation Speaker Program presents an annual series of lectures featuring prominent policy-makers, scholars, journalists, and other opinion leaders who address some of the most pressing issues in healthcare today.

This lecture series was launched in 2001 with Paul Ellwood, MD -- the “father of HMOs” and instrumental in forming federal health policy and reforming private sector systems -- asking a provocative question: “Does managed care need to be replaced?” In subsequent years, industry leaders such as John Wennberg, MD, Director of the Center for the Evaluative Clinical Sciences at the Dartmouth Medical School; John Calfee, PhD, resident scholar of the American Enterprise Institute; and Robert Moffit, PhD, Director of Domestic Policy Studies for the Heritage Foundation joined the list of prominent speakers at this coveted event.

Previous topics of discussion include:

Unwarranted Variations in Health Care Delivery: What’s going on in southern California?
Targeted Therapeutics -- How Biotech Innovations Affect the Cost of Care & Competition Among Firms Marketing Pioneer Drugs
State Health Reform: Revolutionary Possibilities
The series attracts healthcare industry leaders, alumni, faculty and students, among others. Attendees have an opportunity to network and meet the speakers at post-event receptions.


About The Paul Merage School Of Business:

The Paul Merage School of Business at UC Irvine has four dynamic MBA programs -- plus PhD & undergraduate business degrees – that deliver its thematic approach to business education: sustained growth through strategic innovation. We graduate leaders with the exceptional ability to help grow their organizations through strategic innovation -- supported by analytical decision-making, information technology and collaborative execution, and enhanced by a highly-personalized learning environment. In-class and onsite experiences with real-world business issues give our students the edge needed to help companies compete in today’s global economy.

Six Centers of Excellence, an Executive Education program and a variety of conferences and colloquia provide numerous opportunities for students and the business community at large to enhance their education experience and update their professional expertise. While the Merage School is relatively young, it has quickly grown to consistently rank among the top 10% of all AACSB-accredited programs through exceptional student recruitment, world-class faculty, a strong alumni network, and close individual and corporate relationships

In 2008, US News & World Report ranks the Merage School #44 in the US while the Financial Times places the School at #38 nationally, and #68 internationally. BusinessWeek places the School within its Top 50 national listing and specifically ranks faculty research and publications at #20. During the past decade, the School has earned Top 10 rankings both nationally and internationally for its executive MBA program, faculty, curriculum components such as IT and marketing, recruitment services and overall value by such publications as the Financial Times, Wall Street Journal, BusinessWeek and US News & World Report.

The Merage School combines the academic strengths and best traditions of the University of California with the cutting-edge, entrepreneurial spirit of Orange County in the heart of America’s Tech Coast.

About the Center:

The Center for Health Care Management & Policy serves as an interdisciplinary research institute that enables health care scholars, students, business leaders, policy experts, and professionals to share critical knowledge, research, trends, information and education. The Center is under the direction of Paul J. Feldstein PhD, Professor & Robert Gumbiner Chair in Health Care Management.

Source:
Center for Health Care Management & Policy
Paul Merage School of Business, SB 431


top

08-03-2010: Global Pharmaceutical & Biotech R&D: Challenges, Opportunities & Pathways
Global Pharmaceutical & Biotech R&D: Challenges, Opportunities & Pathways
Features Thomas J. Schulze, PHD, PMP, Lead Presenter of Upcoming BioPharmaPM Conference
http://mscholar.com/y2qw


Andover MA USA -- Medical E-Mail News™ / Aug 03 2010 — The pharmaceutical and biotech industries have entered an era of unprecedented change and Action for Results, Inc. (AfR) consultant Thomas J. Schulze, PhD, PMP, plans to guide industry professionals through it in a complimentary webinar, Global Pharmaceutical & Biotechnology R&D -- Challenges, Opportunities & Pathways.

Schulze will address the issues that arise from threats to the industry's current business model including profitability challenges, patent expirations, cost constrained healthcare systems and demanding regulatory requirements.

Additionally, he will help attendees understand the objectives and outcomes necessary for successful drug discovery research, development and commercialization.

There is no charge to attend the webinar, which takes place on Tuesday, August 24 2010, at 1-2 pm Eastern. It is open to the public. Interested parties may register online at: http://mscholar.com/y2qw

Schulze will present further insights for industry professionals in his presentation at BioPharmaPM's annual regional conference Delivering Value through Projects, to be held Sept 21 2010, Reggie Lewis Center, Boston MA. For more information on the conference, please visit http://www.mscholar.com/xgpo

According to Action for Results Marketing Director Janice Laskey, "While pharma and biotech companies are navigating through major changes and future uncertainty, there is potential for significant, positive transformation. Thomas's experience at all levels of the industry -- as a research scientist, chemist and global team leader -- make him an ideal guide for those looking to capitalize upon industry change.

His webinar explores organizational opportunities that promote cross-functional collaboration, agility and the rapid execution that is necessary to work through program risks and issues while delivering value in a constantly changing environment.

"From the project management perspective, Thomas will share his experience organizing, managing and leading teams, functional area managers, and governance and decision-making bodies to meet specific objectives within the value chain, gain efficiencies and reach productivity targets. His experience and knowledge make him an invaluable asset to the industry, especially in these challenging economic times. We are proud to feature him in our free webinar and we look forward to his much anticipated lecture at BioPharmaPM's September regional event," concluded Laskey.

Thomas J. Schulze, PhD, PMP, is a senior consultant at Action for Results, Inc., a California-based entrepreneur and an adjunct faculty member at California State University Channel Islands, where he teaches Entrepreneurial Management, Life Science Creativity & Innovation, and Global Project Management in Pharmaceutical & Biotechnology Drug Research, Development and Commercialization.

Additionally, Dr. Schulze has served as Global Team Leader at Allergan, Inc., Director of Global Project Management R&D at Baxter Healthcare Corporation and in Europe he held Global Project Manager positions at the Bayer AG Pharmaceutical Division in Wuppertal, Germany. Prior to his international management roles, Dr. Schulze held positions of increasing responsibility as medicinal chemist, senior research scientist and research project leader in Bayer Corporate & Pharmaceutical R&D. He earned a PhD in Organic Chemistry from the Freie Universitaet Berlin in Germany. He is also a member of the 101 Biotech Forum, SoCalBIO organization, academic Alexander-von-Humboldt Foundation in Germany and a PMI certified Project Management Professional.

About Action for Results:

Action for Results, Inc. (AfR) is an international consulting company working with healthcare organizations to connect their strategy and execution in order to produce innovative products and services that respond to the needs of patients and customers worldwide. The organization's specialties include strategy definition, organizational capability building, product development process optimization and governance, and portfolio, program and project management. For more information on Action for Results, Inc. and its services, please visit http://www.actionforresults.com

To register for the complimentary webinar, Global Pharmaceutical & Biotechnology R&D -- Challenges, Opportunities & Pathways, please go to http://mscholar.com/y2qw

For more information or to register for BioPharmaPM's Regional Conference, please visit http://www.mscholar.com/xgpo
PMP is a registered trademark of the Project Management Institute, Inc.

Source:Integrated Communications Management



top

08-02-2010: New Medical Group Data Finds Continued Financial Losses in Most Regions

Average Increase in Physician Compensation at 3.8%
http://www.amga.org

Alexandria VA USA -- Medical E-Mail News™ / Aug 02 2010 -- According to findings in the American Medical Group Association's 2010 Medical Group Compensation & Financial Survey, most specialties saw modest increases in compensation in 2009, but many provider organizations continue to operate at a significant loss.

The survey found that 76% of the specialties experienced increases in compensation in 2009, with the overall average increase around 3.8% (in 2008, when 81% experienced an average increase around 3.5%). The primary care specialties (excluding hospitalists) saw about a 3.8% increase in 2009 (same in 2008), while other medical specialties averaged an increase of 2.4% and surgical specialties averaged around 3.8%. (The primary care specialties saw about a 3.8% increase in 2008, while other medical and surgical specialties averaged 6%). The survey reports that during 2009, the specialties experiencing the largest increases in compensation were pulmonary disease (10.37%), dermatology (7%), and urology (6.36%).

"The survey indicates that compensation continues to fluctuate only marginally for most specialties," said Donald W. Fisher, Ph.D., CAE, President/CEO of AMGA. "The modest increases seen this year reflect the negative impact of declining reimbursements, competition for specialists, the cost of new technology, and other factors on practice revenues in most parts of the country."

The section of the survey that examines financial operations found that medical groups were still faced with significant financial challenges. Most regions were doing better than in 2008, but margins are thin. In 2009, organizations in the Eastern and Western regions were operating at break even. Organizations in the Southern region continue to operate at a loss (-1,034 per physician in 2009, -$120 per physician in 2008). Groups in the Northern region continued to experience significant losses (-9,943 per physician in 2009, -$3,254 per physician in 2008).

"In the face of the current economic climate, these medical groups continue to rise to the challenge of delivering the highest quality, coordinated care to the patients they serve," commented Fisher. "Much of the losses we see in 2009 are supplemented by other nonclinical revenue sources and/or funding from health systems with which groups are associated. Most of the groups represented in the survey are part of large organized systems of care that make substantial investments in technology, operations, and the most innovative care processes to best serve populations under their care, and are able to achieve remarkable results for their patients. Our current transaction-based reimbursement system is largely indifferent to these results and to the efforts of medical groups to elevate the standard of care in the US. Currently AMGA is working to address the inequities of the current payment model as part of overall healthcare reform and to develop a model that incorporates a substantial component reflecting achievement of quality results."

The AMGA 2010 Medical Group Compensation & Financial Survey gives a complete financial picture of medical group operations in one volume, providing compensation, productivity, and financial operations data from approximately 49,700 healthcare providers throughout the US, including 121 specialties, 31 other healthcare provider positions, and 27 administrative positions. The survey data includes starting salaries by specialty; medians, means, and percentiles; compensation/productivity ratios; and comparative data from previous surveys, as well as providing analysis by group size and geographic region. In the financial section, profiles are provided per physician FTE, square footage, and work RVU. In addition to staffing profiles, the financial data includes medians, capitation impact, accounts receivable analysis, and department level analysis. A section examines data specific to the academic/faculty practice environment.

About McGladrey:

The 23rd annual AMGA compensation and financial survey was conducted by the national accounting firm of McGladrey. McGladrey is the brand under which RSM McGladrey, Inc. and McGladrey & Pullen, LLP service clients' business needs. Together, they rank as the fifth largest U.S. provider of assurance, tax and consulting services with 7,000 professionals and associates in nearly 90 offices. The two firms operate as separate legal entities in an alternative practice structure. McGladrey & Pullen is a licensed CPA firm that provides assurance services. RSM McGladrey is a leading professional services firm providing tax and consulting services. Both firms are members of RSM International, the sixth largest global network of independent accounting, tax and consulting firms. For more information, visit the McGladrey website: http://www.mcgladrey.com

About AMGA:

The American Medical Group Association represents medical groups, including some of the nation's largest, most prestigious medical practices, independent practice associations, and integrated healthcare delivery systems. AMGA's mission is to improve health care for patients by supporting multi-specialty medical groups and other organized systems of care. The members of AMGA deliver health care to approximately 106 million patients in 49 states, nearly 1 in 3 Americans. Headquartered in Alexandria VA, AMGA is the strategic partner for medical groups, providing a comprehensive package of benefits, including political advocacy, educational and networking programs and publications, benchmarking data services, and financial and operations assistance. http://www.amga.org

To order a copy of the survey:

A limited number of copies of this year's survey are available for working press. For press copies, contact Tom Flatt at tflatt@amga.org. Surveys are also available for purchase for $295 to AMGA members and $590 to nonmembers. To order, visit http://www.amga.org or contact Stefan Rozga at 703-838-0033 ext 326. Survey data is also available in a subscription-based, interactive, online database. For details, contact Stefan Rozga or visit http://www.amga.org

Source: American Medical Group Association


top

07-30-2010: 44th Europlx Pharma Partnering Event Expects Another Record Attendance
Biomedical Market Newsletter® Press Release

44th Europlx Pharma Partnering Event Expects Another Record Attendance
http://www.europlx.com

*Last two events overbooked
*Most international pharma partnering event
*Next euroPLX event filling rapidly

Dielheim/Heidelberg Germany -- Medical E-Mail News™ / July 30 2010 -- 15 Years after the first euroPLX Meeting, which was held on June 20 1995 in Frankfurt Germany, euroPLX has become the pharma industry's most international partnering event, with delegates from an average of 36 countries attending each event.

The first two 2010 events were overbooked. For the organizers, RauCon business development, this is a clear sign that the pragmatic euroPLX concept is favored in difficult economic times, owing to its unique results-to-cost ratio.

The next euroPLX event will be euroPLX 44 Barcelona, to be held on Nov 8-9 2010, in the Hilton Diagonal Mar, Barcelona, Spain. This pharma and biopharma partnering event is already halfway booked. An early registration bonus of EUR 200 will be granted for registrations received by Sept 8 2010.

About RauCon & euroPLX:

euroPLX® (short for European Pharma License Exchange) is a brainchild and Europe registered trademark of RauCon. As a specialist consultancy for providing and organizing business development opportunities, RauCon caters to international pharma and biopharma business development and licensing executives, with organizational tools for the optimization of the business development process, advice and career support.

Having organized partnering events in Europe, North America, and Australia since 1987, RauCon has pioneered the Pharma License Exchange concept in 1995, a novel business development platform for the pharmaceutical industry. Since then each single euroPLX Meeting was meticulously planned and prepared by Dr. Norbert Rau and Mrs. Anke Rau who have an up-to-date perspective on the industry since more than two decades.

Source:
RauCon Business Development
http://www.europlx.com


top

07-28-2010: Diagnostic & Invasive Cardiology Magazine: New Drive Unit Makes Artificial Heart More Practical


Smaller Drive Unit in Clinical Trials May Significantly Lower Hospital Costs
By: Keyur B. Shah MD; Daniel P. Tang MD; Michael Hess MD; & Vigneshwar Kasirajan MD

Virginia Commonwealth University, Richmond VA, Advanced Heart Failure & Mechanical Circulatory Support Program
http://www.syncardia.com


Tucson AZ USA -- Medical E-Mail News™ / July 28 2010 -- The practicality and expense of maintaining patients on total artificial hearts (TAH) may be significantly impacted with the introduction of a new, investigational portable driver unit, researchers announced in a newly-published scientific article.

The 13-pound unit driver is intended to replace the previous 418-pound driver, which will allow eligible patients to be discharged to wait for a transplant heart at home, rather than in a hospital.

The Challenge

The rapidly increasing burden of patients with advanced heart failure has fueled the growing field of mechanical circulatory support. After remarkable progress over the last several decades … read more


About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

Sign-up to receive the latest news updates from SynCardia
For additional information, please visit: http://www.syncardia.com

Source: SynCardia Systems Inc
http://www.syncardia.com


top

07-27-2010: Canadian Cardiovascular Congress Early Bird Registration Closes July 31st
http://www.cardiocongress.org

Do today what many of your colleagues have already done & register early for CCC 2010
Early Bird prices are in effect until July 31 2010
Oct 23-27 2010 -- Montréal Canada
Over 3,800 cardiovascular & allied health professionals to attend
Largest annual event to showcase the best in Canada's cardiovascular research, innovation & care

Montréal Québec Canada -- Medical E-Mail News™ / July 27 2010 — The Canadian Cardiovascular Society's Scientific Program Committee (SPC) has finalized the 2010 Canadian Cardiovascular Congress (CCC), it was announced today. The SPC prides itself on delivering new and exciting programs on an annual basis. This year is no different with the introduction of four new features.

1. Clinical Case Studies:

The volume of submissions exceeded expectations tenfold. Clinical case studies will be presented daily at Congress, from Sunday to Tuesday.

2. Interactive Tutorials - (in the Community Forum):

These 1-hour tutorials will take place in a classroom setting in the Community Forum from Sunday to Tuesday during regular Community Forum hours. Places will be limited (30) and delegates are encouraged to come early to secure theirs.

3. International Symposium:

Expanding the CCC's reach beyond its Canadian borders, the CCS will co-host with the Saudi Heart Association the first International Symposium. Drs K. Al-Habib, H. Al-Faleh, R. Welsh and M. Knudtston are featured during this 90-minute symposium on Tues Oct 26, at 11 am-12:30 pm.

4. Highlighted Guidelines Symposium:

This one-hour guidelines symposium focusing on Atrial Fibrillation takes place in Session Theatre Room 220 B (in the Community Forum) from 12:30 to 1:30 pm on Mon Oct 25.


STELLAR ATTENDANCE IN 2009 FUELS THE COMMUNITY CARDIOLOGY DAY'S RETURN TO THE CCC IN 2010

Now in its second year at CCC, the Year in Review for the Clinical Cardiologist promises again to be a highly interactive and educational session. The Year in Review for the Clinical Cardiologist scheduled for Sat Oct 23, at 7:30 am-1 pm, will kick-start a memorable CCC learning experience. A must attend if you are looking to fit clinically oriented Continuing Medical Education (CME) into your busy schedule.

STEPPING OUT OF YOUR COMFORT ZONE: 9th ANNUAL CARDIOVASCULAR TRAINEE DAY

Sat Oct 23 2010; 7:30 am - 4:30 pm; Le Westin Montréal

The program will consist of 2 keynote plenary sessions and 8 workshops. The keynote plenary sessions feature a presentation by the Montréal Heart Institute's hybrid cardiac catheter lab and global cardiac health opportunities for Canadian trainees. Also new this year will be interactive teaching labs, including echo reading and EKG interpreta tion sessions. Trainees will again have the opportunity to interact with CCS Council, CCSA Board Members, Chiefs of Cardiology, Program Directors and Heads of CV Research Departments, President's of CCS Affiliate societies, during a networking luncheon.

CLINICAL TRIAL ROW:

Clinical Trial Boards provide delegates with an excellent opportunity to learn about planned or ongoing registered clinical trials in Canada. This year, Clinical Trial Row will be prominently displayed on the 5th floor of the Palais de congrès de Montréal from Sunday to Tuesday. There is no cost to submit a Clinical Trial Information Board.

Who Should Attend:

Physicians (cardiovascular specialists, general practitioners, cardiac surgeons, et al.)
Residents, Trainees, Fellows & Medical Students
Pharmacists, Technicians, Nurses
Medical company executives
Media

For further details or to register visit: Cardio Congress website: http://www.cardiocongress.org


MONTREAL CITY NIGHT:

Year after year, this is a sold-out standing-room-only CCC social event. Purchase your tickets today when you register for Congress. Tickets are limited.

Source: Intertask Conferences (Intertask Group of Companies)


top

07-26-2010: Sturgess Company Retained by Medical Device Start-up Company
Sturgess Company Retained by Medical Device Start-up Company
Retained by Ontium Medical Corp of Rancho Santa Margarita CA USA
http://www.sturgesscompany.com


Newport Beach CA USA -- Medical E-Mail News™ / July 26 2010 -- The Sturgess Company, a Newport Beach-based medical marketing, advertising and public relations firm, announced today it has been retained by Ontium Medical Corp.

Ontium Medical, a startup medical device company headquartered in Rancho Santa Margarita CA, is in early stage development and manufacturing of a product that will save time, as well as help reduce costs in hospitals and surgical centers. Another product is in design development for pain management.

The Sturgess Company will be providing Ontium with full-service marketing, advertising and public relations.

About The Sturgess Company:

In addition to medical and healthcare, The Sturgess Company has experience in other industries, including aerospace, high technology, clinical software, consumer products including legal and accounting services. The Sturgess Company, founded in 1990, is a marketing, advertising and public relations firm located in Newport Beach CA. The firm specializes in company identity, market positioning, and brand strategy.

The company's client list includes startup and emerging medical technology companies worldwide. With a primary focus on the medical industry for over 17 years, The Sturgess Company has experience in orthopedics, oncology, hospital pharmacy, clinical research, diagnostics, renal care, emergency medical and IV infusion. The company's business services include the development and implementation of primary and secondary market research, creating and implementing strategic marketing plans and producing comprehensive marketing communications campaigns.

Client experience includes: Advanced Spine, B.Braun, BSKB Intl, Codan US Corp, Conceptus, Curlin Medical, DataLabs, OmniComm Systems, Deloitte, Emergent Respiratory Products, Focus Technologies, G&N Rubicon, Gambro Healthcare, Gear Technology, Gish Biomedical, GPA Intl, Links Medical, M&J Precision Technology, Gear Technology, Surfx Technologies, Proxima Therapeutics, Regenesis, STI Medical, Triad Medical, Triage Medical, Trimarc Financial and US Labs.

Source:The Sturgess Company
http://www.sturgesscompany.com


top

07-22-2010: Crimson Achieves Medical Device Risk Management Milestone:
Crimson Achieves Medical Device Risk Management Milestone:
Industry's First 14971-Registered System Achieves Recertification
IEC 60601 (3rd Ed) Spurs 5-Fold Increase in ISO 14971 GAP Analysis & Registration Activity
http://www.crimsonlanguage.com


Boston MA & San Francisco CA USA -- Medical E-Mail News™ / July 22 2010 — Crimson Life Sciences, a division of TransPerfect and the first ISO 14971-registered company, today announced their recertification to ISO 14971:2007.

The three-year anniversary of the first medical device risk management registration coincides with a 500% increase, industry-wide, in ISO 14971 registration activity. This dramatic increase is directly tied to the specific risk management requirements of IEC 60601 (3rd Edition).

"Given the interest in risk management, some suppliers are claiming ISO 14971 'conformance' or 'compliance' for marketing purposes," says Mark H. Miller, President, Crimson Life Sciences. "Of course, manufacturers should insist on a registered risk management system that is annually audited by a competent registrar, such as UL."

Risk Management's 3-Year Anniversary:

In July of 2006, Crimson completed an extensive Gap Analysis with Dr. Harvey Rudolph, Global Program Manager at Underwriters Laboratories, a 25-year FDA veteran (CDRH), and an original author of ISO 14971. In 2008, Crimson became the first company to successfully register to ISO 14971-the de facto risk management standard for the medical device industry. Now, after one full audit cycle, Crimson has successfully re-certified its pioneering risk management system to ISO 14971:2007-a standard of increasing significance for the medical device industry.

Miller explains, "Last year, we published data that demonstrates the business value of a formal risk management system. Now, the third edition of IEC 60601 confirms our original belief that ISO 14971 will become a key regulatory requirement for all industry participants. This is what led us to obtain the industry's first ISO 14971 registration: a clear understanding that risk management can have a profoundly beneficial impact on the medical device industry." (Click here to read "The Alchemy of Risk Management.")

The third edition of IEC 60601 governs all electrical medical devices and, importantly, contains a normative reference to ISO 14971. This IEC standard imposes a risk management requirement on a large segment of the medical device industry which, according to Notified Body estimates, has increased ISO 14971 registration activity by 500% (year-over-year).

Due Diligence for Labeling Translation:

Crimson's ISO 14971:2007 recertification comes at a crucial time for medical device manufacturers. Labeling scrutiny has become more intense and, according to Notified Body auditors, "major non-conformities are being written for insufficient translation procedures." Crimson is the only translation provider to hold a formal registration to ISO 14971:2007 and their credentials can help manufacturers demonstrate due diligence in their Notified Body audits. Crimson's system is the basis for the industry's only patent pending for labeling translation risk management.

However, warns Miller, manufacturers must exercise caution when sourcing ISO 14971-registered suppliers, "Given the interest in risk management, some suppliers are claiming ISO 14971 'conformance' or 'compliance' for marketing purposes. Of course, manufacturers should insist on a registered risk management system that is annually audited by a competent registrar, such as UL."

Kai Simonsen, Crimson's VP of Production & Quality Systems adds, "Just as important as continued certification of our formal risk management system is an effective integration of risk management processes into our Quality System. Since the elements of risk management mesh very well with ISO 13485, our approach has strengthened our quality processes and produced a true risk management culture in the organization." The first translation provider registered to 13485, Crimson has been continuously certified to 13485 since 2005.

Risk Management Resources at Crimson:

Crimson offers a number of resources on its recently re-launched website. For manufacturers interested in implementing their own risk management system, there is a 30-minute instructional video (at no charge) from ISO 14971 co-author, Dr. Harvey Rudolph. Other resources include a labeling symbols library and an archive of published articles.

About Crimson Life Sciences:

Crimson is a division of TransPerfect Translations International, Inc. and is the only translation practice devoted exclusively to higher-risk medical devices and IVDs. Crimson is the world's first translation firm registered to ISO 13485 and ISO 9001 and the only translation firm registered to ISO 14971. TransPerfect, registered to ISO 9001 and EN 15038, is the world's largest privately held language services provider with more than 60 offices worldwide.

Source: Crimson Life Sciences 
http://www.crimsonlanguage.com


top

07-21-2010: Scientific American Features SynCardia Total Artificial Heart & Freedom™ Portable Driver

Stable Total Artificial Heart Patients Wait at Home for Matching Donor Heart Thanks to 1st U.S. Portable Driver
By Larry Greenemeier
http://www.syncardia.com


Tucson AZ USA -- Medical E-Mail News™ / July 21 2010 -- They say home is where the heart is, but until recently patients who had suffered biventricular failure could survive only with the help of an artificial heart tethered to a large, immobile driver system to maintain blood circulation while they awaited a heart transplant.

This could be changing; artificial heart-maker SynCardia Systems, Inc., in Tucson AZ, last month announced that three patients surgically implanted with the company's technology have been able to walk out of their respective hospitals and wait for donated replacement hearts in the comfort of their own homes... read more

*The Freedom portable driver is currently undergoing an FDA-approved IDE clinical study in the U.S. Through the IDE study, stable Total Artificial Heart patients who meet study criteria may have the option to be discharged from the hospital with the Freedom portable driver, to wait for their matching donor heart at home and in their communities.

About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

Sign-up to receive the latest news updates from SynCardia
For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News

Source:SynCardia Systems Inc
http://www.syncardia.com

top

07-20-2010: Cleaning Validation for Drugs & Biologics Webinar; Strategies for Managing Your Biggest Compliance Challenge; Aug 11 2010
Cleaning Validation for Drugs & Biologics Webinar:
Strategies for Managing Your Biggest Compliance Challenge
Presented by FDAnews: Aug 11 2010 -- 10:00am to 4:45pm EDT
http://www.FDAnews.com/CleaningValidationVC


Falls Church VA USA -- Medical E-Mail News™ / July 20 2010 — On Aug 11 2010, FDAnews is hosting an important new webinar, Cleaning Validation for Drugs & Biologics: Strategies for Managing Your Biggest Compliance Challenge.

What:
From raw materials to finished goods, every contact point in the drug or device processing path creates a contamination risk -- and a new chance to get hit with an FDA warning letter or product recall.

Ten companies have already run afoul of 21 CFR 211 cleaning and validation compliance. For one -- Sumitomo Chemical -- it was the design of a machine that's been in widespread use since 1990.

Your facility could be next. That's why it is critical to clarify and comply with requirements for cleaning solvents, equipment design, training programs, validation and more.

Do you fully understand the FDA's cleaning and validation requirements for equipment and utensils that come in contact with drugs and biologics? Judging by what's turning up during inspections, the FDA is being very clear that many firms don't. Over the past 12 months, serious enforcement actions have included:


Product recalls: Nonsterility prompted a voluntary recall of all lots of Sagent Pharmaceuticals' antimicrobial metronidazole.
Form 483s: The FDA cited King Pharmaceuticals for environmental control violations; machine breakdowns contributed to violations at Nycomed; deficient sanitation and validation were issues for Chem-Tech; incorrect acceptance criteria for leak tests were among nine violations cited at Ben Venue Laboratories; and University of Iowa Pharmaceuticals' validation and training failed to pass muster.
Warning letters: GDMI failed to validate its cleaning procedures; Sumitomo Chemical's equipment design mandated manufacturing changes; and repackager Apotheca was cited for the potential of cross-contamination.

Don't take the chance of being the next violator in the FDA's line of fire. Instead attend this exclusive one-day Virtual Summit, and learn how your cGMPs must change.

At Cleaning Validation for Drugs and Biologics, you'll hear leading industry experts explain exactly what regulations apply and how to make your equipment and processes "violation-proof" before FDA inspectors arrive.

You'll benefit from real-time PowerPoint presentations and real-world examples and case studies. You'll have the opportunity to ask the experts your own questions.

But it's all in the convenience of your own office or conference room -- with your entire team in attendance if you choose -- and no travel or hotel expenses.

Step by step, our expert speakers will help you translate the FDA's expectations into real-world practices, including how to:


Align your cGMPs with 21 CFR Part 211 and ICH quality guidelines
Relate cleaning validation to the FDA's new process validation guidance
Calculate acceptable cleaning validation limits
Set appropriate limits for API, detergents and cleaning agents
Integrate cleaning and validation requirements into equipment design considerations
Measure, inspect and monitor the sanitation processes of manufacturing equipment
Mesh cleaning within a total environmental monitoring program
Create a cleaning validation master plan -- including training documentation
Prepare airtight documentation for cleaning processes, sampling locations and cleaning agents
Streamline cleaning validation methods with a strong QbDE strategy
Identify critical operating restrictions to set the most successful operating ranges

Tap into the expertise of 6 experts on validation & FDA compliance:

The summit chair is Rich Yeaton, president of East Coast Validation. Mr. Yeaton has more than 20 years of experience working in FDA-regulated industries. He recently helped Avecia Biologics, a microbial fermentation contract manager, prepare successfully for its first preapproval inspection.

He was initially introduced to GMP operations and validation on the devices side as a development engineer in DuPont's Medical Products divisions. From there, he helped start Phoenix Imperative, an engineering and validation company serving the biopharmaceutical industry, where he led validation teams at two cell culture facilities to help MedImmune obtain its first two commercial licenses.

Mr. Yeaton has since worked with small startup companies as well as Merck, Genzyme, Wyeth and Lonza, gaining in-depth experience with facility shutdowns and startups. He is a member of the ASME, the ISPE and the PDA and holds degrees in electrical and mechanical engineering from Lehigh University.

He will be joined by a team that includes a senior cleaning validation specialist, engineer, scientist, and two leading industry validation and compliance consultants.

View the complete agenda: http://www.FDAnews.com/CleaningValidationVC

Trouble-shooting training for your entire team -- with no need to travel:

No need to pack your bags for this summit -- it's virtual. Cleaning Validation for Drugs & Biologics uses the Internet and advanced audioconferencing technology to bring a dynamic summit right to your laptop or conference room.

From content-rich PowerPoint presentations by industry experts to handouts, Q&As and breaks, this all-day session will feel just like a powerhouse conference.

The difference? Bring your entire staff for one flat fee with zero hotel and travel costs.

There's even a 24/7 ENCORE presentation included. So, you and your staff can dial in again at any time of day or night for three full weeks after the original summit.

Have everyone attend the full program or assign specific sessions. Either way, you'll come away with smart new strategies that will reduce the delays, frustration and risk of conducting clinical trials in the EU.

Here's How the Virtual Summit Works:

Twenty-four hours prior to the conference date, you will receive all presentations to preview.

A little before 10 a.m. on the day of the summit, just log on to the conference website and dial a phone number, both provided in your registration confirmation. Your summit chair will guide the agenda from there as each expert delivers an information-packed PowerPoint program. Plus, ahead of time and during the program, you can submit questions for the presenter to answer.

Who Will Benefit:

Pharmaceutical & cGMP auditors
Compliance officers & regulatory affairs personnel
Consultants & service providers
Engineering & design control teams
QA/QC personnel
Validation specialists, scientists, engineers
Executive management
R&D staff
Risk management specialists
General/corporate counsel
Investigators
Managers
Manufacturing directors & supervisors
Training personnel
Personnel new to the industry

Register now: http://www.FDAnews.com/CleaningValidationVC



CONFERENCE DETAILS:
"Cleaning Validation for Drugs and Biologics: Strategies for Managing Your Biggest Compliance Challenge"
Aug 11 2010; 10:00am to 4:45pm EDT

TUITION:

$1,297 per site -- includes virtual conference registration and audio CDs and transcripts

4 EASY WAYS TO REGISTER:

Online: http://www.FDAnews.com/CleaningValidationVC
Fax: 703-538-7676
Mail to: FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431

PROGRAM GUARANTEE:

You must be fully satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.

CANCELLATIONS/SUBSTITUTIONS:

Virtual Summit registrations may not be cancelled. Registrants may substitute the 24/7 ENCORE™ audio and Web-based presentations for the live virtual conference at any time. Please contact Customer Service to make any substitutions. No-shows will automatically be sent the 24/7 ENCORE™ login information and speakers' presentations.

ABOUT FDANEWS:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Source: FDAnews


top

7-19-2010: Diversity & Inclusion Healthcare Summit To Explore Impact of New Healthcare Regulation, Aug 3 2010, NYC
Diversity & Inclusion Healthcare Summit To Explore Impact of New Healthcare Regulation
Hosted by the New York Times
To Be Held Aug 3 2010 -- New York Times Conference Center, NYC USA
http://www.regonline.com/register/checkin.aspx?eventid=851810


New York NY USA -- Medical E-Mail News™ / July 19 2010 -- The Diversity & Inclusion Healthcare Summit, hosted by the New York Times, is being presented by WorkplaceDiversity.com in partnership with Learning Works. The summit -- Moving from Talk to Action -- will examine the impact on the workplace as millions more Americans enter the healthcare system.

"The new healthcare regulation is a game changer. It'll affect several industries and by being proactive, we will be able to anticipate and embrace these changes," said Dan Honig, COO of WorkplaceDiversity.com.

The summit will take place on August 3 in the New York Times Building in New York City. It aims to encourage inclusive access by minimizing disparities within the system, as well as discuss strategies for culturally competent healthcare management.

"It is imperative that those who contribute directly or indirectly to the healthcare system remain aware of diversity and inclusion as they work to minimize the disparities in access especially to the emerging majorities within our system," said Carole Weinstein, Chief Learner of Learning Works. "Diversity practitioners, healthcare administrators as well as business leaders can gain insight from this summit," she said.

Speakers:

Speakers for the all-day event include representatives from:
-- Association of American Medical Colleges
-- Duke University
-- North Shore-LIJ Health System
-- Hofstra University Medical School
-- Institute for Diversity in Health Management and others

Details:

For more information on the Diversity & Inclusion Healthcare Summit: Moving from Talk to Action, and a copy of the .pdf brochure with the agenda, please visit: http://www.workplacediversity.com/healthcaresummit or call Dan Honig at 973-992-7311.


Venue:

New York Times Conference Center
620 8th Ave 15th Floor
New York NY 10018

About WorkplaceDiversity.com:

WorkplaceDiversity.com is the source for diversity talent. WorkplaceDiversity.com enables experienced diversity talent to find open positions at companies that support diversity, and to obtain information and resources that will help them attain their career goals.


top

07-16-2010: Methodist DeBakey Heart & Vascular Center Begins Certification Training for World’s Only Approved Total Artificial Heart
Houston Hospital Ranked 19th in Nation for Heart/Heart Surgery by U.S. News & World Report
http://www.syncardia.com


Tucson AZ USA -- Medical E-Mail News™ / July 16 2010 -- On July 8 & 9, the 13-member surgical team from the Methodist DeBakey Heart & Vascular Center in Houston, led by Dr. Matthias Loebe, Surgical Director of the Heart & Lung Transplant Program, completed the first phase of certification training to implant the SynCardia temporary Total Artificial Heart.

“Our hospital currently offers 10 different mechanical circulatory support devices for heart failure patients, but there is only one approved Total Artificial Heart,” said Dr. Loebe. “It is the only device that allows us to replace both the left and right failing heart ventricles. The Total Artificial Heart will allow us to bridge patients to transplant who would’ve otherwise been out of treatment options.”

The Methodist DeBakey Heart & Vascular Center performs more than 1,500 operations annually. In 2009, Methodist performed 23 heart transplants, 8 heart-lung transplants and 26 left ventricular assist device (LVAD) implants. The center was ranked 19th in the nation for Heart/Heart Surgery by U.S. News & World Report for 2009-2010.

Dr. Loebe is an internationally acclaimed researcher and surgeon, who has authored or co-authored more than 200 articles and actively contributes to numerous research studies. He completed residencies in the Department of Surgery at Hannover Medical School and the Department of Thoracic and Cardiovascular Surgery at the German Heart Institute in Berlin. Both hospitals are current SynCardia Certified Centers. Dr. Loebe also completed a Cardiac Surgery Fellowship at the German Heart Institute and served as the Vice Chairman of the Department of Surgery there from 1995-2000.

The Methodist DeBakey Heart & Vascular Center is located in The Methodist Hospital in the Texas Medical Center in Houston. It has 10 operating rooms, eight catheterization labs, 154 acute-care beds, 48 ICU beds and 30 transplant beds. The center receives more than $15 million in research support annually, from sources including the National Institutes of Health and the American Heart Association. In 1987, the Methodist Hospital was recognized as the first Medicare-designated heart transplant center in Texas and one of the first seven in the country.


Dr. Matthias Loebe, Surgical Director
of the Heart & Lung Transplant Program,
Methodist DeBakey Heart & Vascular Center.


About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

Source:
SynCardia Systems Inc

top

 07-15-2010: 2nd Annual Supplier Quality Congress: Assuring Integrity of Drug & Device Raw Materials & Supply Chains
Presented by FDAnews; Aug 18-20 2010; Bethesda MD USA
http://www.SupplierQuality2010.com


Falls Church VA USA -- Medical E-Mail News™ / July 15 2010 — On Aug 18-20 2010, medical industry and related professionals are invited to attend the timely FDAnews conference: The 2nd Annual Supplier Quality Management Congress.

US FDA Commissioner Margaret Hamburg has bluntly told manufacturers to bear responsibility for every step in their supply chain, including more than 330,000 suppliers in 150+ countries.

Are you ready?

Whether your supplier is on the other side of the world, in this hemisphere or right next door ... if a contamination occurs, whether it is accidental or not ... you are responsible. The FDA isn't going to show up and fix your problems.

With the FDA's challenge so clearly articulated, there is no better time for you to act than now. What's your best next step?

Conference Details:

2nd Annual Supplier Quality Congress: Assuring the Integrity of Drug & Device Raw Materials & Supply Chains
Aug 18-20 2010; Bethesda MD USA

Key Speakers:

Last year, this event was a runaway best seller. For 2010, FDAnews has pulled out all the stops to make it even better. Attend and you'll hear from an all-star speaker lineup from both government and industry, including:

Kimberly Trautman, Office of Compliance, CDRH, FDA
Rick Friedman, Director, Div of Mfg & Product Quality, CDER, FDA (Invited)
Steve Niedelman, Sr Consultant, Crowell & Moring
Jackie Torfin, Director of Quality, Arizant Healthcare
Jeff Kasoff, Director of Regulatory Affairs, Life-Tech
Londa Ritchey, Director Supplier Quality, Pfizer
Ames Gross, President, Pacific Bridge Medical
Dan O'Leary, President, Ombu Enterprises

Your conference co-chairs are John Avellanet of Cerulean Associates and Michael Gregor of Compliance Gurus Inc. Their combined experience as executives, authors and consultants to leading industry organizations ensure that the Supplier Quality Management Congress will be the "can't miss" event of summer 2010.

Suppliers Meet Customers Panel:

In addition, because you rely on so many others to make your products, we've invited an exciting roundtable comprised of representatives from top industry groups and companies for an extra-special session you won't want to miss.

This "suppliers meet customers" panel will help foster the cooperation and compliance needed to thrive under that current financial and regulatory scrutiny.

Participants will include:


Society of Chemical Manufacturers & Affiliates (SOCMA)
International Pharmaceutical Excipients Council (IPEC)
Rx-360
Active Pharmaceutical Ingredients Committee (APIC)
Society of the Plastics Industry (SPI)
National Electrical Manufacturers Association (NEMA)
DuPont

Register today for the invaluable pre-conference workshops.

Arrive early on Wed Aug 18 and take advantage of the in-depth instruction at our two pre-conference workshops. This year, in concurrent workshops, we're covering how to write expert supplier quality agreements for medical devices or pharmaceuticals.

Workshop A:

Creating Comprehensive Medical Device Supplier Quality Agreements That Reduce Risk & Improve Contract Deliverables
-- Dan O'Leary, President, Ombu Enterprises

A quality agreement is a written contract between client and supplier that is intended to prevent critical details from "falling through the cracks." While these contracts are required by regulations and guidance, there are not clear expectations. The lack of clarity does not stop the FDA from issuing Form 483s regarding these agreements. This workshop will illustrate the content and format of quality agreements and emphasizes important but often overlooked details.

Attendees will:


Learn how to use a process flow diagram to identify critical control points and tasks that need to be addressed in the quality agreement
Discover how to avoid potential quality problems by identifying and addressing them in advance
Specify operational expectations within the limits of each party's capabilities -- making sure each party can do what is expected, needed and wanted
Workshop B:

Creating Pharmaceutical Supplier Quality Agreements
-- John Vajda, Managing Consultant, BFC Consultants

While these contracts are required by regulations and guidance, there are no clearly outlined expectations for them. ICH Q7A 16.12 simply reads "There should be a written and approved contract or formal agreement between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality measures, of each party." Case studies of actual quality agreements will be presented to illustrate how much variation there can be in content and format, to show strengths and weaknesses in the documents, and to illustrate the potential consequences of an inadequate quality agreement.

Attendees will:


Use tools to build a solid document that addresses the expectations of both parties
Discover how to avoiding potential quality problems by identifying and addressing them in advance
Specify operational expectations within the limits of each party's capabilities -- making sure the other party can do what you expect, need and want

Click here to see the full conference brochure.

Who Will Benefit:


Quality assurance/quality control
Operations
Manufacturing
Materials management
Purchasing
Packaging and labeling
Plant engineering
Laboratory quality control
Regulatory affairs
Legal counsel

About Your Co-Chairs:

John Avellanet, Principal Consultant, Cerulean Associates
John Avellanet is a former medical device and biopharma executive who created, developed and ran a Fortune 50 subsidiary's records management and information technology departments. He co-founded Cerulean in 2006, and today is an internationally acknowledged expert, speaker and syndicated author on lean FDA compliance and FDA/ICH Quality by Design. He is a regular columnist for the quarterly Journal of Commercial Biotechnology, where he writes on the practical aspects of compliance, quality systems and preventing industrial espionage, and the magazine Pharmaceutical Processing, where he writes about IT compliance issues such as Part 11 and Annex 11.

Michael Gregor, President, Compliance Gurus Inc.
Michael Gregor is the president of Compliance Gurus Inc., a premier compliance consulting and software solution provider. Prior to forming his own company, Mr. Gregor acquired over 20 years of experience in the FDA regulated industry. His areas of compliance expertise include: biological, OTC and pharmaceutical drugs, cosmetics, dietary supplements, foods and medical devices. Mr. Gregor has distinguished himself as an industry authority. He has provided compliance guidance to several Fortune 500 companies, which include Pfizer, Schering-Plough, Monsanto, Wyeth and Boston Scientific. In addition, Mr. Gregor has authored several published articles and white papers concerning GCP, GLP and GMP issues.

Tuition:

Early Bird (until July 20 2010) $1,797 per attendee for conference and workshop
Regular Tuition (July 21-Aug 20 2010) $1,997 per attendee for conference and workshop

4 Easy Ways To Register:

Online: http://www.SupplierQuality2010.com
By phone: 888-838-5578 or 703-538-7600
Fax: 703-538-7676
Mail to: FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431

Program Guarantee:

You must be fully satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.

Cancellations/Substitutions:

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted -- nor refunds issued -- within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Team Discounts:

Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call 703-538-7600 for details.

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Source:
FDAnews



top

 07-12-2010: 2nd Annual Next Generation Dx Summit: Moving Assays To The Clinic -- Aug 24-26 2010, Washington DC
http://www.nextgenerationdx.com

Development, Commercialization, Clinical Adoption of Novel Assays
Advance registration discount deadline: July 23 2010
Aug 24-26 2010 -- Washington DC


Needham MA USA -- Medical E-Mail News™ / July 12 2010 -- Cambridge Healthtech Institute is hosting its Building on last year's inaugural success, the Summit is designed to bring together all of the major players in the Molecular Diagnostics arena. The advance registration discount for the Summit ends July 23 2010.

The four meetings comprising the event (Enabling Point-of-Care Diagnostics, Trends in Cancer Diagnostics, Molecular Diagnostics for Infectious Disease, and Co-Development of Drugs & Diagnostics) will showcase advances in technology, research and diagnostic development, with an emphasis on applications to meet the demands of the clinic.

Speakers:

The Next Generation Dx Summit will feature several interesting Keynote Speakers, including: Jeffrey S. Ross, M.D., Albany Medical College and Foundation Medicine and Harry Glorikian, Managing Partner of Scientia Advisors, who will be talking about shaping the future of cancer pathway-based medicine. Franklin R. Cockerill, III, M.D., Mayo Medical Laboratories and Mayo Collaborative Services, Inc., and Christine C. Ginocchio, Ph.D., M.T. (ASCP), North Shore-LIJ Health System Laboratories, will be addressing the future of point-of-care for infectious disease.

The Summit features over 60 speakers who will present on topics covering trends for rapid diagnosis, early detection, novel therapies, and accelerating progress of companion diagnostics. Just a few of the confirmed speakers include: Hakan Sakul (Sr Director & Global Head, Pfizer Global R&D), Jeffery K. Taubenberger (Chief, Viral Pathogenesis, NIH), Steven Buchsbaum (Sr Program Officer, Bill & Melinda Gates Foundation), Hans Lehrach (Director, Max Planck Institute for Molecular Genetics, Berlin), Gary W. Procop (Chair, Dept of Molecular Pathology, Cleveland Clinic), Cathy Petti (Global Head, Novartis Infectious Disease & Diagnostics), Robert Dunstan (Distinguished Investigator, PCDS, Biogen Idec), and Cynthia Gawron-Burke (External Scientific Affairs, Merck Research Laboratories).

Additionally, there are two pre-conference short courses on Mon Aug 23 2010. These are dynamic, information-rich sessions. Topics include Commercialization of Molecular Diagnostics, and an Overview of Micro- & Nanofluidics. There is also a dinner short course on Wed Aug 25 2010, on the Future of Point-of-Care Platforms.

There are plenty of other highlights as well, including breakout discussion groups, which present the opportunity to discuss relevant topics in small group settings. This year's Exhibit Hall will feature an expanding number of exhibit booths and extensive poster presentations.

For more information on the Next Generation Dx Summit, please visit the event website: http://www.nextgenerationdx.com

About Cambridge Healthtech Institute:

Cambridge Healthtech Institute (CHI), founded in 1992, is the industry leader in providing superior-quality scientific information to eminent researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett International, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, and Cambridge Healthtech Media Group.

Source:
Cambridge Healthtech Institute

top

07-08-2010: Conducting Clinical Trials in the EU: Secrets for Managing Speedy & Compliant Trials; Virtual Conference
Presented by FDAnews; July 29 2010; 10:00am -- 4:45pm EDT
http://www.FDAnews.com/EUClinicalTrialsVC


Falls Church VA USA -- Medical E-Mail News™ / July 08 2010 -- The upcoming virtual conference -- Conducting Clinical Trials in the EU: Secrets Revealed for Managing Speedy & Compliant Trials -- will take place July 29 2010, FDAnews has announced.

Issues:

Countries such as the UK, France, Poland, Sweden and Italy offer tremendous advantages for drug and device developers. But conducting clinical trials in the EU can be challenging and unpredictable.

Now medical industry companies and professionals can learn the inside story of how to successfully navigate development faster in the EU -- without running into compliance problems or triggering costly delays.

Despite the Clinical Trials Directive (CTD), EU member states still vary wildly on clinical trial applications, ethics committee approvals and reporting of SUSARs.

There is also widespread inconsistencies in adherence to the CTD's timelines, fees and principles of informed consent. Inspections can occur without notice. Even small privacy/data issues can cause big problems.

What are the secrets for conducting a wide range of EU clinical trials to support efficient global drug development? This virtual summit brings you expert answers you can put into action right away.

"On The Ground" intelligence available from no other source:

For the first time, this FDAnews virtual summit brings together six top experts on conducting clinical trials in the EU -- including the virtual summit chair, Clinquest's Dr. Jack McLane.

Attend via laptop or gather your entire team in the conference room. You'll view dynamic PowerPoint presentations in real-time as these noted speakers use case studies and EU-insider intelligence to clarify exactly how the EU differs from the U.S. and how you can integrate all the various regulatory provisions into one speedy and successful program for bringing drugs and devices to market. Plus, you'll be able to ask the speakers your own questions.

Mark your calendar now for this full day of guidance, including:

The top 5 EU countries for clinical trials: understanding the regulations in the UK, France, Poland, Sweden and Italy
How to avoid the manufacturing, shipping and even insurance issues US firms face when conducting EU trials
How to comply with privacy and security laws as you collect, process, transmit and retain clinical trial and adverse event data
How the "Road Map Initiative for Clinical Research in Europe" could affect your trials and what its future is likely to be
What both sponsors and sites must know about research and ethics committees and the roles they play in each member state
Best practices for managing postmarket and pharmacovigilance-related trials in the EU
How to quickly secure insurance for EU clinical trials

Hear from 6 experts on international drug development:

The summit chair is Dr. John (Jack) McLane, COO/VP of Clinical & Regulatory Affairs for Boston-based Clinquest. Dr. McLane has more than 20 years of experience in all phases of international lifecycle development with both large and small pharmaceutical companies.

Dr. McLane has led more than 50 clinical programs to successful INDs, NDAs and EMEA/CTA applications. He was the initial developer of novel vitamin D-derived compounds for Roche, was a group leader for NDA filings in Parkinson's and Alzheimer's diseases, and has served at companies including Ariston Pharmaceuticals, Milkhaus Laboratory, Hoffman-La Roche and Roche Laboratories.

Dr. McLane will be joined by experts from top US and European companies plus officials from EU organizations, including the European Forum for Good Clinical Practice and the European Organization for Research and Treatment of Cancer.

View the complete agenda

High-quality training for your entire team -- without the hassle and expense of traveling:

No need to pack your bags for this summit -- it's virtual. Conducting Clinical Trials in the EU uses the internet and advanced audioconferencing technology to bring a dynamic summit right to your laptop or conference room.

From content-rich PowerPoint presentations by industry experts to handouts, Q&As, and breaks, this all-day session will feel just like a powerhouse live conference. The big difference is that you can bring your entire staff for one flat fee -- with zero hotel and travel costs. There is even a 24/7 ENCORE presentation so you and your staff can dial in again at any time of day or night for three full weeks after the original summit.

Have everyone attend the full program or assign specific sessions. Either way, you'll come away with smart new strategies that will reduce the delays, frustration and risk of conducting clinical trials in the EU.

How the Virtual Summit Works:

Twenty-four hours prior to the conference, you will receive all presentations to preview.

A little before 10:00 am on the summit day, just log on to the conference website and dial a toll-free number, both provided in your registration confirmation. Your summit chair will guide the agenda from there as each expert delivers an information-packed PowerPoint program. Plus, ahead of time and during the program, you can submit questions for the presenter.

Who Will Benefit:

EU clinical operations staff
Scientific and medical directors
Regulatory affairs personnel and liaisons
Patient recruitment/clinical trial enrollment staff
Clinical/R&D operations and research staff
Clinical quality assurance/control personnel
Clinical outsourcing: planning and vendor management staff
Strategic business development/operations staff
Project/study management/project planning personnel
Clinical trial capacity planning and management staff
Clinical trial process improvement and enhancement staff
Clinical compliance personnel
Clinical safety personnel

Register now:

CONFERENCE DETAILS:

Conducting Clinical Trials in the EU: Secrets Revealed for Managing Speedy and Compliant Trials -- Virtual Conference
July 29 2010 -- 10 am-4:45 pm EDT

Tuition:

$1,297 per site -- includes virtual conference registration and audio CDs and transcripts

To Register:

Online: http://www.FDAnews.com/EUClinicalTrialsVC
Fax: 703-538-7676
Mail to: FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431

Program Guarantee:

You must be fully satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.

Cancellations/Substitutions:

Virtual Summit registrations may not be cancelled. Registrants may substitute the 24/7 ENCORE™ audio and Web-based presentations for the live virtual conference at any time. Please contact Customer Service to make any substitutions. No-shows will automatically be sent the 24/7 ENCORE™ login information and speakers' presentations.

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Source:
FDAnews

top

 06-29-2010: Joins Faculty At UC San Diego
World Renowned Total Artificial Heart Pioneer Dr. Jack Copeland
Joins Faculty At UC San Diego
Acclaimed Heart Surgeon Made World’s Only Approved Total Artificial Heart a Reality
http://www.syncardia.com


Tucson AZ USA -- Medical E-Mail News™ / June 29 2010 -- On July 1, Total Artificial Heart pioneer and world renowned heart surgeon, Dr. Jack Copeland, will join the faculty at the new $227 million Sulpizio Family Cardiovascular Center at the University of California, San Diego in La Jolla.

“If it weren’t for Dr. Copeland’s decades of work, the SynCardia temporary Total Artificial Heart would not be the world’s only approved Total Artificial Heart today,” said Rodger Ford, CEO of SynCardia Systems, Inc., manufacturer of the Total Artificial Heart. “Dr. Copeland’s tireless efforts helped make the Total Artificial Heart the world’s most successful bridge to transplant device. He has and will continue to play a vital role in training new SynCardia Certified Centers, proctoring their first implants and improving patient outcomes.”

Dr. Copeland made medical history in 1979 when he performed Arizona’s first heart transplant, and again in 1985, when he became the first surgeon to successfully use the Jarvik 7 artificial heart as a temporary bridge to transplant. The first five implants of this artificial heart had been for permanent use only.

Dr. Copeland’s numerous contributions to the Total Artificial Heart include advancing surgical technique, patient care protocols and anticoagulation (blood management), and serving as the Principal Investigator of the 10-year pivotal clinical study of the Total Artificial Heart. This clinical study produced the highest bridge to transplant rate, 79%, of all approved mechanical circulatory support devices today, and resulted in FDA approval of the Total Artificial Heart in October 2004.

Dr. Copeland is a founder and past president of the International Society for Heart and Lung Transplantation (ISHLT). Besides his pioneering work with the Total Artificial Heart, Dr. Copeland also performed Arizona's first heart-lung transplant in 1985 and the first U.S. implant of a pediatric ventricular assist device designed for newborns and small children.

“I came to Arizona because it was a welcoming environment in which I could try new things that would benefit patients,” said Dr. Copeland, who has performed more than 100 implants of the Total Artificial Heart. “I now have the same feeling about UCSD… but I will miss my patients. They have been some of the sickest and bravest souls I have ever seen.”

“I will miss my patients. They have been
some of the sickest and bravest souls
I have ever seen,” said Dr. Jack Copeland
of his 33-year surgical career in
Southern Arizona.


Photos Available:

Dr. Jack Copeland
Press Conference: 1st Use of Jarvik 7 as a Bridge to Transplant
Dr. Jack Copeland with Total Artificial Heart recipient Bill Wohl
SynCardia temporary Total Artificial Heart and Human Heart


About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

Sign-up to receive the latest news updates from SynCardia
For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News

Source:
SynCardia Systems Inc

top

 06-25-2010: HealthAchieve 2010 Conference & Exhibition, Nov 8-10 2010 Toronto Ontario Canada
Marketing Availabilities Announced For Award-Winning Health Care Conference & Trade Show
http://www.healthachieve.com

HealthAchieve2010 Conference & Exhibition
Nov 8-10 2010 -- Metro Toronto Convention Centre, Toronto Ontario Canada
Attracting over 9,400 in 2009, HealthAchieve provides a dynamic & cutting-edge showcase of the latest innovations in technology; presents dynamic learning possibilities; & allows for networking among today's top health care & business leaders

Toronto Ontario Canada -- Medical E-Mail News™ / June 25 2010 -- Planning for HealthAchieve -- the largest health care gathering of its kind in North America -- is off to a roaring start with strong exhibit floor sales and a brand-new partnership, meeting organizers said today.

HealthAchieve has partnered with COACH, Canada's Health Informatics Association, to bring their Fall Forum together with HealthAchieve to deliver the eHealth track at this year's conference and exhibition. Through their dedication to promoting a clear understanding of health informatics, COACH will help to create a strong and dynamic eHealth track that should inspire delegates and exhibitors alike.

More about HealthAchieve:

Established in 1924, the show is celebrating its 86th anniversary this year.
Delegates attending HealthAchieve are typically CEO's, Board Chairs/Board Members, Vice Presidents, Directors, and Managers of hospitals and health care associations.
The attendance figure from HealthAchieve2009 (9,474) exceeded the 2008 show's attendance by 5% in spite of the challenging economic situation.
In 2009, a total of 350 exhibiting companies occupied 455 booth spaces. For the last nine years, the Exhibit Floor has been sold out with a waiting list.
HealthAchieve's Exhibit Floor continues to feature special areas like Green Lane and Silicon Alley.
The Exhibit Floor was international in scope in 2009, with exhibitors participating from Canada, the US, China, UK, Ireland, South Korea, and Denmark.
HealthAchieve2009 featured a total of 63 sessions, breakfasts and receptions. A total of 230 speakers participated in the show.
HealthAchieve2009 supported Toronto's economy by selling out room blocks in five major downtown hotels.
HealthAchieve continues to provide a venue for a large number of health care students from colleges and universities, profiling the many openings that are available in the health care sector.
HealthAchieve is consistently recognized as one of the largest and most respected health care conferences of its kind. Recently, HealthAchieve was recognized with the 'Best Trade Show' Award from the Canadian Event Perspective Magazine Star Awards.
For the second year in a row, HealthAchieve will be partnering with the Ontario Ministry of Health and Long-Term Care (Ministry) to feature Celebrating Innovations in Health Care Expo, a showcase of leading-edge health care projects and government initiatives from across the province. This partnership with the Ministry will bring an even greater number of delegates to HealthAchieve.
In 2010, HealthAchieve is staying connected to delegates and exhibitors through popular social networking sites including Facebook, Twitter and LinkedIn. Delegates and exhibitors are encouraged to check out the sites for the latest HealthAchieve news and information.

HealthAchieve's Exhibit Floor is 1/2 sold out with sales continuing at a rapid pace. The Early Exhibit Space booking deadline is June 30, 2010 and with limited space available, exhibitors are encouraged to book today to avoid disappointment.

For a floor plan highlighting exhibit space availability.

For a detailed listing of 2010 exhibitors.

For exhibitors who find that their competitors are already registered to exhibit at HealthAchieve2010, this may be one of the best reasons to attend. Delegate lists from 2009 -- which include those hard-to-reach health care decision-makers -- are also available from the website.

HealthAchieve provides many sponsorship openings and customized packages to suit the needs of any organization. Advertising is also available.


SOURCE:
HealthAchieve 2010



top

 06-24-2010: New Study Indicates Significant Improvement in Survival for Patients with Advanced pNETs
New Study Indicates Significant Improvement In Progression-Free Survival
For Patients With Advanced Pancreatic Neuroendocrine Tumors
Results to be presented at: ESMO 12th World Congress on Gastrointestinal Cancer

Alpharetta GA USA -- Medical E-Mail News™ / June 24 2010 -- Groundbreaking studies will be presented at the ESMO 12th World Congress on Gastrointestinal Cancer next week in Barcelona, Spain, including exciting new data on treatment for neuroendocrine tumors. “The presentations this year are very significant for clinicians, and outline real progress in the development of agents that are effective in managing and treating gastrointestinal diseases,” says Eric Van Cutsem, MD, PhD of the University Hospital Gasthuisberg in Leuven, Belgium and Congress co-chair.

New data on neuroendocrine tumors

What may be most significant to clinicians is an important development in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET). James Yao of the University of Texas MD Anderson Cancer Center in Houston TX USA, will present results from a large phase III clinical trial (RADIANT-3) on everolimus (RAD001), an oral inhibitor of mTOR, indicating a prolongation of progression-free survival with everolimus considerably higher compared to placebo. “Treatment options for patients with advanced pNET are limited, and these results are exciting,” says Van Cutsem, who also worked on the study. “This is a very meaningful development.”

A second pNET study of immediate interest to clinicians investigated the quality of life in patients with progressive pancreatic NET receiving sunitinib, and results indicate overall clinical benefit across all patient subgroups studied.

New phase 3 studies

Results of significant clinical trials of new therapies in pancreatic and colorectal cancer will also be presented at the Congress. A phase III trial of aflibercept plus gemcitabine in patients with metastatic pancreatic cancer and another phase III study comparing larotaxel to 5-FU (continuous intravenous 5-FU or capecitabine) in patients with advanced pancreatic cancer previously treated with a gemcitabine-containing regimen did not achieve the hoped-for results. Final results of a third phase III study of sunitinib plus FOLFIRI in first-line treatment of patients with metastatic colorectal cancer do not indicate a significant improvement in PFS in patients.

Updated information on new treatment in colorectal cancer

Updates on new treatments in colorectal cancer (CRC) will be presented for the first time in Barcelona, including results of studies of the SRC inhibitor dasatinib, the hedgehog pathway inhibitor GDC-0449, and AKT inhibitor perifosine.

Updates on new targeted agents in gastric cancer

Two of the top abstracts in gastric cancer this year address the clinical objective of more effective treatment options. Investigators in the phase III AVAGAST trial, which was first presented earlier this month at ASCO, will report final efficacy and safety data of this very new and important study on the role of bevacizumab. In addition, quality of life results from a phase III study of trastuzumab plus chemotherapy as first-line therapy in patients with HER2-positive advanced gastric and gastro-esophageal junction cancer will be presented.

Noteworthy presentations by researchers will also include updates on the progress that is being made in molecular profiling of colon cancer and several important reports on large clinical trials in colorectal cancer.

Nearly 400 studies overall will be presented at the ESMO 12th World Congress on Gastrointestinal Cancer, outlining research taking place across the globe. 16 researchers from developing nations who received grants based on the scientific merit of their submitted work will also be recognized. Additionally, a consensus expert report on gastric cancer will be presented.

The ESMO 12th World Congress on Gastrointestinal Cancer, developed and managed by Imedex, begins next week in Barcelona, Spain and runs June 30-July 03 2010.

Registration is available onsite: http://www.worldgicancer.com

# # #
Gastrointestinal Cancers

Gastrointestinal cancers include anal cancer, colorectal cancer, esophageal cancer, gallbladder cancer, gastric cancer, liver cancer (hepatoma), pancreatic cancer, and small intestine cancers. The most prevalent of these is colorectal cancer in the Western world and gastric cancer in Eastern world. Colorectal cancer is a major public health problem in Western countries, with the highest incidence rates in North America, Western Europe, Australia and New Zealand. It is the third most common cancer in both men and women, and the third most common cause of cancer death in both sexes. About 630,000 deaths from colorectal cancer are expected this year worldwide, accounting for 8% of all cancer deaths. Gastric is the second most frequent cause of cancer related mortality, accounting for +/- 800,000 deaths each year worldwide.

About ESMO

The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care.

ESMO’s mission is to advance cancer care and cure through fostering and disseminating good science that leads to better medicine and determines best practice. In this way ESMO fulfils its goal to support oncology professionals in providing people with cancer with the most effective treatments available and the high-quality care they deserve.

The ESMO community is a powerful alliance of more than 6,000 committed oncology professionals from over 100 countries. As a trusted organization with 35 years of experience and over 500 expert officers, ESMO serves its members and the oncology community through: a brand of excellence in post-graduate oncology education and training; leadership in transforming evidence-based research into standards of cancer care in Europe; dedicated efforts to foster a more favorable environment for scientific research; innovative international platforms to share expertise, best practices and disseminate the most up-to-date scientific research to as wide an audience as possible.

ESMO’s scientific journal, Annals of Oncology, ranks among the top clinical oncology journals worldwide. ESMO events are the meeting place in Europe for medical oncologists to update their knowledge, to network and to exchange ideas.

To find our more about ESMO, please visit http://www.esmo.org

About Imedex

Imedex® is an industry leader in providing accredited, independent continuing medical education to health care professionals. We develop high quality, scientific programming that translates the latest research into clinically relevant information. Imedex activities have exceptional organization and outstanding educational value, with a proven sustained impact on disease management.

Our established relationships with the leading investigators and researchers in medicine, and some of the world's most prestigious societies and organizations, make our educational offerings the most effective in the industry. These specialists are widely recognized international authorities who provide fair and balanced presentations of the most clinically-significant and relevant information. Our comprehensive programs are designed utilizing advanced adult educational principles in order to ensure that key learning objectives are identified, measured, and achieved.

Imedex programs focus on improving patient care around the world. With over 50,000 e-learning experiences annually and more than 97,000 live meeting attendees since 2001, Imedex truly educates the global healthcare community. At Imedex, we believe that education is the best medicine.®

Source:
Imedex LLC




top

 06-17-2010: SynCardia Named Among Top 50 Companies to Watch by Medical Device & Diagnostic Industry Magazine
SynCardia Named Among Top 50 Companies to Watch by Medical Device and Diagnostic Industry Magazine
Total Artificial Heart Manufacturer is Only Company to Make the List with an FDA-Approved Mechanical Circulatory Support Device
http://www.syncardia.com


Tucson AZ USA -- Medical E-Mail News™ / June 17 2010 -- Medical Device and Diagnostic Industry (MD+DI) magazine has selected SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, as one of 50 Companies to Watch for 2010.

MD+DI's Reason to Watch: "The SynCardia Total Artificial Heart is the only device of its kind with regulatory approval in the United States, Canada, and Europe. The device, meant for people dying from end-stage biventricular failure, works similar to a heart transplant in that it replaces both the right and left heart ventricles. Plus, there's no waiting list like there is for donor hearts (the company has certified centers set up throughout the world)."

SynCardia recently received conditional approval from the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the 13.5 lb Freedom™ driver (photo), the first ever U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. The first U.S. patient was discharged from the hospital on May 3. In Europe, where the Freedom driver has CE approval, two patients have been discharged home, one in Nantes, France and one in Moscow, Russia.

SynCardia (http://www.syncardia.com) is the only company with an approved mechanical circulatory support (MCS) device to make the list. MCS devices include left ventricular assist devices (LVADs), biventricular assist devices (BiVADs) and SynCardia's Total Artificial Heart.

MD+DI solicited nominations from readers, its Editorial Advisory Board and Reader Board, and industry observers, and analyzed nominee information before producing the list.


About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News

Source:
SynCardia Systems Inc

top

06-16-2010: UC Irvine Posts Taped Webcast Online Of Health Policy Debate
UC Irvine Posts Taped Webcast Online Of Health Policy Debate
Webcast of 19th Annual 2010 Health Care Forecast Conference is now posted at:
http://www.merage.uci.edu/go/hccvideo


Irvine CA USA -- Medical E-Mail News™ / June 16 2010 -- The UC Irvine taped webcast of its 19th Annual 2010 Health Care Forecast Conference, is now available for viewing online, UCI officials announced today. There is no charge to access the Feb 25-26 2010 educational series, at: http://www.merage.uci.edu/go/hccvideo

This annual conference is presented by the Center for Health Care Management at the Paul Merage School of Business, University of California, Irvine. The webcast is supported by the California HealthCare Foundation, based in Oakland CA.

Over the past 19 years, the annual Health Care Forecast Conference has become a leading national forum for discussing the economics and politics of healthcare. Each conference includes an economic forecast for the healthcare industry, a federal budget outlook, updates on state healthcare issues, and the latest industry trends, giving participants a broader and deeper understanding of the forces that affect the way health care is delivered in the US.

This highly respected event provides knowledge and insights to leaders in the private and public healthcare sectors who are grappling with complex problems during an era of unprecedented change.

Leading authorities and prominent keynote speakers such as Norman J. Ornstein PhD, television commentator and Resident Scholar at the American Enterprise Institute, addressed important issues facing business and government.

2010 is an election year, and has seen health care reform legislation passed and signed into law. The impact of health care reform, affecting 16% of the U.S. economy, was discussed at length by industry insiders, as well as by Dr. Ornstein, whose Keynote Address provided insight on the policy debate in Congress from an inside-the-beltway perspective.

In addition to policy-related issues, the conference also discussed the impact of new technologies that are transforming healthcare delivery and the competitive forces in the marketplace that influence business strategies of all segments of the health care market.

Timely issues are the focus of candid dialogue among conference attendees, which include physicians, nurses, top executives from provider and insurer organizations, as well as pharmaceutical, medical device, biotech, and other healthcare firm employees, and government officials.

SPEAKERS:

Keynote Speaker:
Norman J. Ornstein PhD
Resident Scholar
American Enterprise Institute, TV News Commentator

Richard R. Afable MD MPH
President
Hoag Memorial Hospital Presbyterian

Joseph R. Antos PhD
Wilson H. Taylor Scholar
American Enterprise Institute

James R. Baumgardner PhD
Deputy Asst Director for Health Policy
Congressional Budget Office

Jay J. Cohen MD MBA
President & Chairman
Monarch HealthCare

Kevin Counihan
Chief Marketing Officer
Commonwealth of Massachusetts Health Insurance
Connector Authority Board

Michael V. Drake MD
Chancellor
UC Irvine

Paul J. Feldstein PhD
Professor & Robert Gumbiner Chair in Health Care Management
Paul Merage School of Business, UC Irvine

Donald Furman MD MBA
Co-Founder & Chief Medical Officer
CareMore

Jon R. Gabel PhD
Senior Fellow
Health Policy & Evaluation National Opinion Research Center

James E. Glassman PhD
Senior Economist & Managing Director
JP Morgan Chase & Co

Karen Ignagni
President & CEO
America's Health Insurance Plans

Jeffrey Korsmo
Executive Director
Mayo Clinic Health Policy Center

Robert J. Margolis MD
CEO
HealthCare Partners

Christine Metz
Sr VP Sales
Welvie
Former Regional VP
Anthem Blue Cross

Michael A. Mussallem
Chairman of the Board & CEO
Edwards Life Sciences Corp

Len Nichols PhD
Professor of Health Policy
George Mason University

Kavita Patel MD
Former Director of Policy
White House Office of Public Engagement & Intergovernmental Affairs

Ronald A. Paulus MD MBA
Executive VP, Clinical Operations & Chief Innovation Officer
Geisinger Health Plan

Andrew J. Policano PhD
Dean
Paul Merage School of Business, UC Irvine

Thomas M. Priselac
President & CEO
Cedars-Sinai Health System &
Immediate Past Chair
American Hospital Association

Dean A. Rosen JD
Principal
Mehlman Vogel Castagnetti Inc
Former Health Policy Dir for Senate Majority Leader William H. Frist MD

Murray N. Ross PhD
VP, Kaiser Foundation Health Plan Inc
Director
Kaiser Permanente Institute for Health Policy

Steve Sell
President & CEO
Health Net of California

Sheryl R. Skolnick PhD
Managing Director
Pali Capital Inc

Mark Werner MD
Executive VP & Chief Medical Officer Carilion Clinic
Roanoke Memorial Hospital

Tom Williams
Executive Director
Integrated Healthcare Association

ABOUT THE PAUL MERAGE SCHOOL OF BUSINESS:

The Paul Merage School of Business at UC Irvine has four dynamic MBA programs -- plus PhD & undergraduate business degrees – that deliver its thematic approach to business education: sustained growth through strategic innovation. We graduate leaders with the exceptional ability to help grow their organizations through strategic innovation -- supported by analytical decision-making, information technology and collaborative execution, and enhanced by a highly-personalized learning environment. In-class and onsite experiences with real-world business issues give our students the edge needed to help companies compete in today’s global economy.

Six Centers of Excellence, an Executive Education program and a variety of conferences and colloquia provide numerous opportunities for students and the business community at large to enhance their education experience and update their professional expertise. While the Merage School is relatively young, it has quickly grown to consistently rank among the top 10% of all AACSB-accredited programs through exceptional student recruitment, world-class faculty, a strong alumni network, and close individual and corporate relationships

In 2008, US News & World Report ranks the Merage School #44 in the US while the Financial Times places the School at #38 nationally, and #68 internationally. BusinessWeek places the School within its Top 50 national listing and specifically ranks faculty research and publications at #20. During the past decade, the School has earned Top 10 rankings both nationally and internationally for its executive MBA program, faculty, curriculum components such as IT and marketing, recruitment services and overall value by such publications as the Financial Times, Wall Street Journal, BusinessWeek and US News & World Report.

The Merage School combines the academic strengths and best traditions of the University of California with the cutting-edge, entrepreneurial spirit of Orange County in the heart of America’s Tech Coast.

About the Center:

The Center for Health Care Management and Policy serves as an interdisciplinary research institute that enables health care scholars, students, business leaders, policy experts, and professionals to share critical knowledge, research, trends, information and education. The Center is under the direction of Paul J. Feldstein PhD, Professor & Robert Gumbiner Chair in Health Care Management.

SPONSORS:

Principal Benefactor
-- California HealthCare Foundation

Major Benefactors
-- CIGNA Health Care of California
-- Hoag Memorial Hospital Presbyterian
-- Kaiser Permanente

Benefactors
-- Anthem Blue Cross
-- AON Consulting
-- Beckman Coulter Foundation
-- Blue Shield of California

Co-Benefactors
-- Orange County Medical Association

Source:
Paul Merage School of Business
University of California

top

 06-15-2010: FDA Recall Branch Chief Added As Instructor To Upcoming Regulatory Training In Anaheim CA
FDA Recall Branch Chief Added As Instructor To Upcoming RegulatoryTraining In Anaheim CA
http://www.fdaconsulting.com/train.shtml


Irvine CA USA -- Medical E-Mail News™ / June 15 2010 -- Rita Hoffman, Recall Branch Chief, US FDA, CDRH has just been added as an instructor to the Complaint, MDR, Recalls and Vigilance for Devices training course to be held at the Disneyland Resort in July. Ms. Hoffman is responsible for the oversight and review for all medical device recalls submitted to FDA for health risk classification. With over 30 years with FDA, she brings a wealth of information and experience in which medical device manufacturers can benefit and prepare for the inevitable correction or removal of a device.

Noblitt & Rueland will hold important regulatory compliance training courses in June & July 2010, with all events to be held at the Disneyland Resort in Anaheim CA USA.

• How to avoid regulatory enforcement action in the current new compliance environment
• Topics that have become top priority for FDA reviewers & compliance inspectors
• June & July 2010 -- Disneyland Resort, Anaheim CA USA

Topics that have become top priority for FDA reviewers and compliance inspectors will be covered, to help protect you and your company from regulatory enforcement actions and the headaches that accompany them.

SCHEDULE: (attend any 1 or more training programs)

JUNE COURSES (Next week): DISNEYLAND RESORT, ANAHEIM CA USA

June 21 2010; Mon -- Design Control, FDA & ISO
June 22 2010; Tue -- Risk Management, ISO 14971 & FDA Requirements
June 23 2010; Wed -- Software, the FDA & ISO including Part 11 Update
June 24 2010; Thu -- Software Verification & Validation Strategies
June 25 2010; Fri -- IEC 60601-1 3rd Edition (transition dates are impending)

JULY COURSES: DISNEYLAND RESORT, ANAHEIM CA USA

July 19 2010; Mon -- FDA Quality System Regulation (QSR/GMP) & FDA Inspections
July 20 2010; Tue -- ISO 13485:2003 Implement & Maintain
July 21 2010; Wed -- Auditing Quality Systems for FDA & ISO Compliance
July 22 2010; Thu -- Complaints, MDRs, Recalls & Vigilance for Devices (Rita Hoffman, Recall Branch Chief, US FDA, CDRH has just been added as an instructor)
July 23 2010; Fri -- CE Marking: Medical Devices, IVDs & MDD Revisions

VENUE:

Disneyland Resort, Anaheim CA USA
Special course discounts, including multiple attendee discounts, are available.

COURSE DESCRIPTIONS:

TO DOWNLOAD A SEMINAR BROCHURE:

TO REGISTER:

FOR REGISTRATION & HOTEL INFORMATION:

CRITICAL ISSUE HIGHLIGHTS: FDA & ISO MEDICAL DEVICE HOT TOPICS:

NEW ADMINISTRATION in the White House and new FDA Commissioner means new direction for the FDA. Expect greater enforcement and regulation. Recent high profile cases and outside agency government reports indicate that additional enforcement, oversight, and regulation are on the horizon. We will be discussing any strategic changes by the agency and their impact on you and other medical device manufacturers.
ENFORCEMENT IS VERY COSTLY. Recent judgments and enforcement by the FDA should motivate companies and their management to ensure that their company is compliant with the Quality System (QS/GMP) regulations. Enforcement actions resulting from GMP/QS regulation violations have been very serious and have included consent decrees, $100+ mln & $500+ mln fines, corporate warning letters, injunctions to stop manufacturing due to QSR and Design Control issues, and international firms receiving import detention, etc. A recent US District court complaint against a US medical device manufacturer specifically cites inadequate quality system training of both employees and management in support of a seizure order.
RISK MANAGEMENT & ISO 14971 HAVE BECOME ESSENTIAL TO THE MEDICAL INDUSTRY. We will be discussing the impact of this standard and other risk standards and what manufacturers need to do to comply. This course will discuss risk techniques, ISO 14971, and how to comply with risk requirements of the FDA and other regulatory groups worldwide. This course will describe details of what to do, how to conduct risk and hazard analysis, and how to comply.
GLOBAL HARMONIZATION TASK FORCE has released a final guidance document on the Implementation of Risk Management activities within a Quality Management System as well as Guidelines for Regulatory Audit Reports and proposed guidance related to Control of Suppliers.
DESIGN CONTROL CONTINUES TO BE A MAJOR FOCUS DURING FDA QUALITY SYSTEM INSPECTIONS. Warning Letters continue to site design control issues found during FDA Quality System/GMP inspections. Many companies continue to experience problems effectively implementing design control.
NEW INTERNATIONAL SOFTWARE STANDARDS; SUCH AS IEC 62304, ARE IMPACTING MANUFACTURERS. The FDA has also published a SOFTWARE GUIDANCE DOCUMENT for use by FDA reviewers and manufacturers. It is important to understand the impact of these documents on manufacturers and designers of medical devices on submissions (510(k), PMA, CE Mark) and FDA inspection compliance.
FDA INSPECTIONS Continue To Site Design Control & CAPA Subsystems As Problem Areas. Warning Letters repeatedly site Corrective & Preventive Action & Design Control problems found during FDA Quality System/GMP inspections. Many companies continue to experience problems effectively implementing FDA compliant Quality Systems.
21 CFR PART 11 NEW REGULATION IS EXPECTED SOON. We will be discussing the latest information on Part 11 and electronic recordkeeping requirements.
SOFTWARE VERIFICATION & VALIDATION USING A RISK-BASED APPROACH IS CRITICAL FOR COMPLIANCE. Companies can demonstrate software compliance in product submissions, such as 510(k), PMA, IDE and CE Mark submissions; Part 11 compliance in Quality Systems; and software validation of automated systems used in manufacturing and quality systems per FDA guidance and the new AAMI TIR 36 guidance.
IEC 60601-1 3RD EDITION HAS MANY MAJOR CHANGES FROM THE PREVIOUS VERSION, INCLUDING A STRONG FOCUS ON RISK MANAGEMENT ACTIVITIES. It is important to understand how this new edition may soon impact your medical electrical equipment. Without compliance to the changes found in this new edition, your ability to release and sell your product may soon be impacted. Some products will be impacted as early as this October.
ISO 13485:2003 IMPLEMENTATION & MAINTENANCE IS CRITICAL TO CONTINUE MARKETING PRODUCTS INTERNATIONALY. Prepare now for your surveillance renewal audit by being able to show your registrar or notified body proof of proper documented training. If you need in-house training before this course offering please contact us for a quotation.
REQUIREMENT FOR INTERNAL AUDITING WHEN PERFORMED EFFECTIVELY HAS SAVED MANY COMPANIES BOTH ENFORCEMENT HEADACHES & PENALTIES. Companies have avoided negative competitive and investor relations by finding and correcting deficiencies prior to FDA inspections. These corrections have prevented FDA enforcement actions and Warning Letters from being issued, published on the Internet, and being available to competitors for distribution to customers. In addition, many companies have found that investors become nervous when FDA enforcement actions occur. Obviously, many times the firms experience a negative impact to their stock price or funding.
COMPLAINT HANDLING & MDRs PROVIDE EARLY WARNING TO COMPANIES & FDA. Numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties, have been levied on companies that failed to properly report events and take proper corrective and removal action when necessary. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required.
SEVERITY OF ENFORCEMENT PENALTIES HAS INCREASED. Repeat offenders and management should beware of this worsening potential.

DOWNLOAD A PROGRAM BROCHURE:

COURSE-SPECIFIC INFORMATION INCLUDES A BRIEF OUTLINE FOR EACH COURSE:

REGISTER ONLINE AT:
http://www.fdaconsulting.com/registerform.shtml
or by fax at 714-258-3990.

FOR ADDITIONAL HOTEL & REGISTRATION INFORMATION:

Printed brochures and registration are available by phone at 714-258-4646 or 888-892-4664 (in the US & Canada).

For immediate response, please send your message to:
info@fdaconsulting.com
and do not reply to this email, or contact us by phone at 714-258-4646, or fax at 714-258-3990.

Source:
Noblitt & Rueland

top

 06-08-2010: Pharmaceutical Labeling Summit, July 22-23 2010, National Press Club, Washington DC
Pharmaceutical Labeling Summit:
From FDAAA to SPL to REMS: Navigating the FDA’s New Focus
http://www.PharmaLabelingSummit.com

-- Presented By FDAnews
-- To Be Held July 22-23 2010, National Press Club, Washington DC


Falls Church VA USA -- Medical E-Mail News™ / June 08 2010 -- Whether it’s the age-old battle of getting a label approved -- or emerging conflicts over postmarket revisions -- labeling remains one of the most intense negotiations the drug industry has with the US Food & Drug Administration (FDA).

Come to Washington July 22-23 2010, and attend FDANews' Pharmaceutical Labeling Summit: From FDAAA to SPL to REMS -- Navigating the FDA’s New Focus, where key FDA officials and industry experts will all be in one room, waiting to assist companies, their counsel and regulatory affair representatives on this important topic.

Labeling has always been a factor, but today approvals and revisions have taken on a whole new dimension with the FDA’s new emphasis on careful deliberation and approval of new drugs (not to mention post-market safety).

Consider:


The key drug labeling case of Wyeth v. Levine, in which the US Supreme Court held that federal regulatory approval of a medication does not shield the manufacturer from liability under state law
Ongoing challenges with off-label promotion in the wake of hard-hitting prosecutions by US attorneys resulting in multimillion-dollar legal settlements
New SPL format rules and their effect on labeling and medical communications

This coming July, there will be an exceptional opportunity for you to buttonhole key FDA players, plus the top lawyers, industry experts and others who are able to clarify new labeling requirements.

Speakers:

FDAnews has designed this conference with you in mind. The all-star lineup will feature the following distinguished speakers:

Capt. Laurie Beth Burke -- Leader, Study Endpoints & Label Development Team, CDER, on how her Office of New Drugs approaches the labeling process
Lonnie Smith -- FDA Data Standards Council, on SPL shapes labeling
Gerald Masoudi -- Partner, Co-chair, Food & Drug Practice Group, Covington & Burling LLP, former Chief Counsel, FDA, on how FDAAA Sec. 505(o)(4) allows for mandated labeling changes
Coleen Klasmeier -- Partner, Sidley Austin, Former Special Assistant to the Chief Counsel, FDA, on the FDA-approved label as a form of "scientific speech"
Dr. Robert Epstein -- President, Medco Research Institute, on the intersection of pharmacogenomics and labeling
Daniel Kracov -- Partner, Arnold & Porter, on the fallout from Wyeth v. Levine and how to manage preemption considerations in FDA submissions

The summit chair is Alan Hassell, former Drug Regulatory Affairs Specialist for Hoffmann-La Roche. He’ll share boots-on-the-ground implementation strategies for effective core data sheets and implications for local labels.

Topics:

Held within the intimate National Press Club, attendees will participate in a mix of presentations and panel discussions regarding:

How preemption considerations in the wake of Wyeth v. Levine affect labeling
Why REMS and other FDAAA requirements impact submissions and regulatory negotiations
What you should know about section 505(o)(4) of FDAAA and how it affects labeling interactions between a sponsor and FDA
What safety data the FDA expects you to be reviewing and how resulting signals might affect revisions in labeling
Best practices for integrating medically driven decisions with regulatory labeling changes
Understanding the regulatory standards the FDA review divisions use for including an indication or other benefit information in package inserts and how much and what type of data are needed to support certain kinds of benefit information
Has the recent FDA guidance on medical and scientific journal articles increased or decreased the distribution of off-label information
What's the impact of pharmacogenomics and labeling on employer and health plan payers as they consider drugs and genetic testing?

Meet Your Chair:

Alan Hassell is an independent consultant with more than 30 years of experience in the pharmaceutical industry. Previously, Alan was a regulatory affairs specialist at Hoffmann-La Roche. There he was in charge of the creation and maintenance of core data safety (CDS) labeling documents. He reviewed, evaluated and approved local product documents (LPDs) and performed safety analysis to support core labeling changes. Before Hoffmann-La Roche, Mr. Hassell was a senior director at Duck Flats Pharma where he worked on clinical and preclincal data compliance. Previously, as the manager of worldwide labeling, safety and risk management with Pfizer, Mr. Hassell worked with CDS labeling documents, LPDs, safety analysis and with Pfizer Country Organization regulatory managers to revise local labeling according to headquarters standards and local regulations. He is a recipient of the FDA Commissioner's Special Citation and was recognized for his participation and insight while a member of the Structured Product Labeling Working Group and for its work developing the "SPL Implementation Guide for FDA Content of Labeling Submission."

Who Will Benefit:

VP/Director Global Labeling
Global Regulatory Affairs
Promotional Regulatory Affairs
Regulatory Affairs Labeling
Labeling and Product Communications
Scientist, Regulatory Affairs
Chief Regulatory Counsel
Chief Medical Officer
VP/Director Global Patient Safety
Corporate Counsel
Outside Counsel

Conference Details:

Pharmaceutical Labeling Summit: From FDAAA to SPL to REMS -- Navigating the FDA’s New Focus
July 22-23 2010 (Thursday and Friday)
National Press Club
529 14th St. NW
Washington DC 20045
http://www.PharmaLabelingSummit.com

Tuition:

Early Bird Registration: $1,797 per attendee (available until June 23 2010)
Regular Registration: $1,997 (June 24-July 22 2010)

4 Easy Ways to Register:

Online: http://www.PharmaLabelingSummit.com
By phone: 888-838-5578 or 703-538-7600
Fax: 703-538-7676
Mail to: FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431


Program Guarantee:

You must be entirely satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.

Cancellations/Substitutions:

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted -- nor refunds issued -- within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Team Discounts:

Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call 703-538-7600 for details.

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Source:
FDAnews

top

06-07-2010: 13th Annual Cardiothoracic Update & TEE Review Course, Aug 5-8 2010, Hilton Head SC USA
Duke University Medical Center Dept of Anesthesiology 13th Annual Cardiothoracic Update & TEE Review Course
Registration Deadline for lowest room rate is July 12 -- Early-bird registration deadline is tomorrow
Aug 5-8 2010 -- Sea Pines Resort, Hilton Head Island SC USA
http://anesthesiology.duke.edu/modules/anes_cme_ctregcc/index.php?id=1


Durham NC USA -- Medical E-Mail News™ / June 07 2010 -- Duke University Medical Center Department of Anesthesiology announced new details today of its 13th Annual Cardiothoracic Update and TEE Review Course, taking place at Sea Pines Resort, in sunny Hilton Head Island, South Carolina, Aug 5-8 2010. This four-day course will focus on changing the scope of anesthesiology practice and increasing knowledge among anesthesia, critical care, and perioperative healthcare providers.

Additionally, the course will address the need for interdisciplinary discussion of the changing practice of cardiac surgery, cardiothoracic anesthesia, TEE, perfusion strategies, and cardiac assist device management.

The conference features 4 exciting days of educational events focusing on:

Cardiothoracic surgical techniques relevant to anesthesiologists, perfusionists and critical care nurses
Assist device management
Critical care issues
Transesophageal echocardiography
Hands-on workshops including:
* Perfusion techniques
* Organ preservation in cardiac surgery
* Airway management
* Porcine heart guided dissection - the 'wet lab'
A 'mock' TEE exam by experts

Includes an anatomical wet lab:

The meeting will also include an anatomical wet lab where each participant, in order to gain a better understanding of cardiac anatomy, will dissect a porcine heart guided by a cardiac surgeon. A mock TEE examination will also be conducted as a workshop for participants planning to take the NBE exam. The meeting will feature a TEE simulator, which will be used to demonstrate the technique of TEE and the correlation of echocardiographic images with heart anatomy.

At the conclusion of this activity, participants should be able to:

Examine the pertinent issues in the perioperative management of cardiac and thoracic surgical patients.
Discuss the important factors for improving the quality of an intraoperative TEE service.
Evaluate recent developments in cardiothoracic anesthesia and be able to relate these advances to everyday practice situations.

Target Audience:

This event is designed to educate and/or refresh the knowledge of healthcare professionals caring for patients undergoing cardiac, thoracic and vascular surgical procedures.

Faculty:

Madhav Swaminathan, MD, FASE, FAHA
Associate Professor of Anesthesiology
Duke University Medical Center

Course Faculty

Mark Berry, MD
Kevin Collins, CCP
Myra Ellis, RN
Katherine Grichnik, MD, FASE
Steven Hill, MD
Patrick Hranitzky, MD
Chad Hughes, MD
G. Burkhard Mackensen, MD, PhD, FASE
Aman Mahajan, MD, PhD
Feroze Mahmood, MD
Joseph P. Mathew, MD, FASE
Carmelo Milano, MD
Alina Nicoara, MD
Mihai Podgoreanu, MD, FASE
Joseph Rogers, MD
Svati Shah, MD
Andrew Shaw, MD, FRCA, FASE
Mark Stafford Smith, MD, CM, FRCPC, FASE
Richard Walczak, CCP

CEU credits:

The Duke University School of Medicine designates this educational activity for a maximum of 28.25 AMA PRA Category 1 credit(s)(tm) for physicians. The American Board of Cardiovascular Perfusion (ABCP) has approved this activity for a maximum of 35 CEU credits. The AANA has accredited this educational activity for a maximum of 28 CE credits.

Online registration:

Early-bird registrations deadline is June 8 2010. To register online and view the fee schedule please visit our website at:
http://anesthesiology.duke.edu/modules/anes_cme_ctregcc/index.php?id=5

Hotel reservations:

A hotel block has been established and guaranteed through July 12 2010 at Sea Pines resort, with a guest room or 1-bedroom villa rate of $199 and a 2-bedroom villa rate of $239. Individual reservations can be made online at: http://www.seapines.com

Select reservations/group reservations and use conference code DUKE or via telephone by calling the Sea Pines Resort, Hilton Head Island at 843-842-1874. You must refer to the room block for "Duke University Medical Center."

Source:
Department of Anesthesiology
Duke University Medical Center

top

 06-02-2010: Laboratory Safety Institute (LSI) Announces Lab Safety Training Courses

For Industrial, Biotech, Forensic, Environmental, R&D, Hospital Labs & Universities
1-3 day courses available onsite, on location & as webinars
http://www.LabSafetyInstitute.org


Natick MA USA -- Medical E-Mail News™ / June 02 2010 -- The Laboratory Safety Institute (LSI), an international center for health, safety and the environment, announced details today of its lab safety training courses for industrial, biotech, forensic, environmental, R&D, hospital labs and universities. These 1-3 day courses are presented onsite, on location and as webinars.

Topics:

The 3-day/24-hour short course is a “Lab Safety Boot Camp” that covers the following topics: 3 C’s of Safety, Scope of the Problem, Accidents, Legal Aspects of Safety, OSHA Lab Standard, Biological & Animal Hazards, Eye & Face Protection, Storage of Chemicals, Labeling, Ventilation, Compressed Gases, Record Keeping, Radiation, Blood Pathogens Standard, Fire Control, Handling Chemical Reagents, Disposal of Chemicals, Needs Assessment, Electrical Safety, Lab Inspection, and Review of Inspection results, Employee/Student Involvement, and Safety Program Planning.

Registration:

Register at http://www.LabSafetyInstitute.org by clicking on the “Register for a course” Link. Save 5%. Mention the code: BMN510 (may be combined with other discount offers).

LSI’s 1 and 2-day short courses, plus webinars, can be similarly accessed for registration. A complete list of the courses can be viewed by selecting the tab “LSI’s Training Courses” at LSI’s website.

Lab Training schedule for 2010:
http://www.labsafetyinstitute.org/resources/Seminar+Dates+Online.pdf

24-Hour Short Course Schedule:

June 08-11 - Portland OR
June 15-18 - Scranton PA
June 22-24 - San Marcos TX
July 06-09 - Reno NV
July 13-16 - San Diego CA
July 20-23 - Seattle WA
July 26-29 - Ithaca NY
July 27-30 - Charleston SC
Aug 03-06 - Delaware OH
Aug 10-13 - Boston MA
Aug 17-20 - Greencastle IN

Upcoming Webinars: Webinars begin at 11 am EST & run 60-90 minutes:

June 11 2010 - Chemical Waste Management
July 23 2010 - Complying with the OSHA Lab Standard
Aug 09 2010 - Eye & Face Protection
Sep 20 2010 - Leadership in Safety
Oct 22 2010 - Developing a more Effective Lab Safety Program
Nov 12 2010 - Regulatory Compliance in the Laboratory
Dec 10 2010 - Complying with OSHA Bloodborne Pathogen Standard

Who should attend LSI’s Lab Safety Training Programs:

EHS Staff & Managers
Lab Managers
Lab Supervisors
Lab Workers
Scientists
Science Educators
Science/Technology
School Administrators
Risk Managers
Safety/Security Directors
Facilities Managers
Anyone who wants a better safety program

Lab training course participants receive:

270-page course notebook filled with valuable safety information -- forms, checklists & examples to enhance your lab safety program
1-year individual membership to LSI
Certificate of participation
Continuing Education Units (CEU’s)
American Board of Industrial Hygiene (ABIH) Certification Maintenance (CM) points for certain courses. Useful for industrial hygienists & others who require CM points as a job requirement
Graduate Credit eligibility -- (LSI) short course participants can earn graduate credit from the University of San Diego (USD); 1-3 semester-hour credits are awarded for the successful completion of LSI’s short courses plus additional work
Discounts on purchases


Registration fees:

1-day Seminar 2-day Short Course 24-Hour Short Course

1 person $395 (*$330) 1 person $595 (*$505) 1 person $795 (*$675)
2-4 persons $345 2-4 persons $525 2-4 persons $695


*Early Registration Discount:

Register 60 or more days prior to the course and save 15%. Applies to an individual registration and cannot be combined with any other discount. Full payment must be received at least 30 days prior to course for discount to apply.

Other services provided by LSI include:

Inspections/Audits
Environmental Auditing
Safety program development -- Consultation & Review
Regulatory Compliance Assistance
Designing, Remodeling & Building Safer Labs
Leadership In Safety Training for Management, Administration & Supervisors

Details of the above services can be viewed by selecting the tab “LSI’s services” at LSI’s website: http://www.LabSafetyInstitute.org

LSI works with you:

To learn about cost effective options, call Dr. Kaufman at 508-647-1900. LSI works with you to identify topics to be emphasized to provide comprehensive lab safety training specific to your needs. Your time constraints will be accommodated by arranging training sessions from a few hours to a few days in length, in person or by webcast.

LSI also provides the services below at no charge:

Answering questions from around the world on lab, occupational residential, health & safety issues
Moderating LSI’s internet discussion list, Labsafety-L, to discuss lab safety issues and concerns
Conducting conference call consultations

Products/publications provided by LSI include:

LSI publications
LSI’s Speaking of Safety newsletter
Safety posters for labs
Audio/Video/DVD course material
LSI distributes a full range of lab & occupational safety books & media from other publishers

Membership:

You can also become an LSI member to help support safety in science education. Individual and organizational memberships are available.

Individual Member Benefits:

1-yr subscription to Speaking of Safety newsletter
Use of LSI's Audio-Visual Lending Library (Members pay only shipping/handling fee)
10% discount on publications
5% discount on fees & registrations to seminars
Year round mailing of seminars and special events held in your area
Lab Safety Program Discussion

Organizational Member Benefits:

Everything listed above
5 memberships for the price of 3
A Lab Safety Program Development Review (no charge)

About Laboratory Safety Institute:

LSI has been providing lab safety training and services for well over 3 decades since its inception in 1978. Over 65,000 science teachers, educators, administrators, scientists and lab workers have been trained by LSI and counting.

Source:
Laboratory Safety Institute

top

 06-01-2010: FDA-OCRA 13th Annual Educational Conference Workshop Set For Irvine CA

For Regulatory/QA/QC & Technical Professionals in Medical Device, Drug, Biologics, OTC, Generics & Dietary Supplements
June 16-17 2010 -- Irvine Marriott Hotel, Irvine CA USA
http://www.ocra-dg.org


Irvine CA USA -- Medical E-Mail News™ / June 01 2010 -- Orange County Regulatory Affairs Discussion Group (OCRA) in conjunction with FDA Centers and the FDA Los Angeles District Office, is hosting its 13th Annual FDA-OCRA Educational Conference, set for June 16-17 2010, at the Irvine Marriott hotel in Irvine CA USA.

This year the focus of the popular two-day event is “The Business of Compliance,” featuring a keynote address by Michael Chappell, US FDA Acting Associate Commissioner for the Office of Regulatory Affairs.

The first day plenary session includes important topics such as FDA Strengthening Roles in Enforcement & Compliance, Global Supply Chain Management, an International Regulatory Update, and Enforcement Activities.

To Register Online (please log on first):
http://www.ocra-dg.org

The second day provides attendees with the valuable opportunity to participate in these important various breakout sessions:

Medical Devices & IVDs:

eMDR
CDRH Update
Global Regulatory Update
FDA Inspections

Drugs/Biologics/OTC/Generics:

CMC Update
Regulation of Emergent Technologies
NDA Regulatory Review
Compliance Update
FDA Inspections

Dietary Supplements:

Regulatory Update
Claims &Marketing
GMP Update
FDA Inspections

As the primary focus of the 2-day program is enforcement and compliance, each breakout session will address FDA-inspection related topics, and a final Plenary Panel Session will be held at the end of the meeting to wrap-up this very import topic of compliance.

The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA affording you maximum interaction with both Los Angeles District and Washington-based FDA personnel. Over the years, the collaborative efforts of FDA and OCRA have consistently brought more and more FDA and industry staff together for this Educational Conference. It's a great place to network with your colleagues in the industry and government.

Who Should Attend:

Those in regulatory affairs/compliance, clinical affairs/auditors, legal, quality assurance/quality control, marketing & advertising, product development, consultants, entrepreneurs, analysts, operations & management.

Speakers:

Michael Chappell -- Acting Associate Commissioner, Office of Regulatory Affairs, US FDA
Antoinette Azevedo -- President, e-SubmissionsSolutions.com
Ofelia U. Barretto -- President, Compliant Quality Solutions
Cindy Beehner -- President, QSD Consulting
Mark Benke -- Director of Corporate Stability, Amgen Inc
Maryavis Bokal -- Sr Intl Trade Specialist, U.S. Dept of Commerce (USDOC)
Raymond Brullo DPM FAPWCA -- Compliance Officer, US FDA Los Angeles District
Alonza E. Cruse BS -- District Director, US FDA Los Angeles District
Brian Donato -- Director, Hyman, Phelps & McNamara, P.C.
Robert Dormer Esq -- Director, Hyman, Phelps & McNamara, P.C.
Daniel Fabricant PhD -- VP, Global Govt & Scientific Affairs, Natural Products Association
Rick Flora -- President, R. Flora & Associates
Mike Havert PhD -- Biologist, Office of Cellular, Tissue & Gene Therapies, CBER, US FDA
Eri Hirumi RAC -- Regulatory Affairs Manager, Beckman Coulter, Inc.
Drew Kelner -- Executive Director of Analytical & Formulation Sciences, Amgen Inc.
Paul Kramsky -- VP, Global RA, Bausch & Lomb, Inc
C. Stephen Lawrence Esq -- Partner, Hogan & Hartson L.L.P.
Joan Loreng -- Biologics National Expert, US FDA (retired)
James R. Lusk -- US/EU RAC, Principal, Quality Systems Intl
Diane Minear -- VP, Medical Devices, Weinberg Group Inc.
Richard Morroney -- VP, Global Market Clearance Solutions, Clinivations, Inc.
Steven Niedelman -- Sr. Consultant, Crowell & Moring LLP (former Deputy Assoc Commissioner, US FDA)
Regina O'Meara -- Director of Govt Affairs, Beckman Coulter, Inc.
Ken Phelps -- President & CEO, Camargo Pharmaceutical Services, LLC
Eugene Reilly -- Public Health Analyst, Office of Surveillance & Biometrics, CDRH, US FDA
Carl Reynolds -- Contractor to FDA, DSP, ONLDS
Matt Rink -- Manager Product Operations, Alcon Laboratories
Dan Schultz MD FACS -- Sr VP, Medical Devices & Combination Products, Greenleaf Health, LLC (former Director CDRH, US FDA)
Steve Silverman -- Acting Sr Advisor to the Center Director, CDRH, US FDA
Ann M. Stahl -- Investigator, Western Region, US Federal Trade Commission
Dr. Ekkehard Stosslein -- Deputy Head of Dept Medical Devices, & Head of Section Active Medical Devices, Federal Institute for Drugs & Medical Devices, BfArM (German Competent Authority)
James Wang PhD RAC -- Consultant, Regulatory Affairs & Biometric Operations
Steven Wolfgang PhD -- Acting Assoc Director, Regulatory Science, DMPQ, CDER, US FDA

Why You Should Attend:

Plenary topics:

1. FDA: Strengthening Roles in Enforcement & Compliance
2. Global Supply Chain Management:
-- Managing a growing and diverse supplier base with shrinking resources
-- Supply chain deficiencies, 483 citations & Warning Letters
3. Intl Regulatory Update
4. Enforcement Activities of Significance
-- Consent Decrees 2009 (KV Pharmaceuticals, Caraco, & CareTech)
-- Stories from the trenches

Attend 3 Separate Breakout Sessions:

Medical Devices & IVDs: eMDR, CDRH Update, Global Regulatory Update, FDA Inspections
Drugs/Biologics/OTC/Generics: CMC Update, Emergent Technologies, Compliance, FDA Inspections
Dietary Supplements: Overview & Regulatory Update, Claims & Marketing, GMPs, FDA Inspections

Location:

Irvine Marriott
18000 Von Karman Ave
Irvine CA 92612
949-553-0100 phone
http://www.marriott.com/hotels/travel/laxir-irvine-marriott

Conference Chairs:

Alonza E. Cruse BS -- District Director, US FDA Los Angeles District
Christine Posin RAC -- Consultant

Registration Fees:

$725 OCRA Members
$775 Nonmembers (includes 2010 OCRA membership)
$475 FDA/Government/Students

About OCRA:

Orange County Regulatory Affairs Discussion Group (OCRA) is a nonprofit volunteer organization comprised of regulatory affairs professionals from the southern California area who are interested in participating in educational programs and networking with one another. OCRA membership includes those who work in life sciences industries, such as medical devices, pharmaceutical, biologics, IVD and dietary supplements. OCRA is comprised of over 700 members representing about 180 medical device, pharmaceutical, biotech, and biologics companies in Orange County and the surrounding areas. OCRA members represent professionals in the small start-up companies to the larger established organizations.

Source:
Orange County Regulatory Affairs Discussion Group

top

 05-27-2010: Mayo Clinic Discharges 1st SynCardia Total Artificial Heart Patient in U.S. History
Mayo Clinic Discharges 1st SynCardia Total Artificial Heart Patient in U.S. History
Father of Three Goes Home Using Freedom™ Portable Driver after 600+ Days in the Hospital
http://www.syncardia.com


Tucson AZ USA -- Medical E-Mail News™ / May 27 2010 -- On May 3, Mayo Clinic Arizona became the first hospital in U.S. history to discharge a patient implanted with the SynCardia temporary Total Artificial Heart to wait at home for a matching donor heart. Mayo Clinic is participating in an FDA Investigational Device Exemption (IDE) clinical study of the Freedom™ driver, the first ever U.S. portable driver designed to power SynCardia’s Total Artificial Heart both inside and outside the hospital.

Charles Okeke, 43, was implanted with the SynCardia Total Artificial Heart on Sept. 3, 2008, after his body rejected a previous donor heart transplant. For more than 600 days, Charles was confined to the hospital by the 418-lb hospital driver nicknamed “Big Blue” that powered his Total Artificial Heart.

Then, on March 26, 2010, SynCardia Systems, Inc., received conditional approval from the FDA to conduct an IDE clinical study of the Freedom portable driver in the U.S.

“When the Total Artificial Heart was implanted in 2008, I felt better than I had in years,” said Charles. “Now, through the IDE clinical study, I’m able to wait at home for a donor heart with Natalie, my wife of 12 years, and our three children ages 4, 6 and 11.”

Weighing only 13.5 lbs including two rechargeable, lithium-ion Onboard Batteries, the Freedom driveris designed to be carried by the patient in the Freedom Backpack or Shoulder Bag.

The IDE clinical study is approved to enroll 60 patients at up to 30 institutions. The IDE clinical study is intended to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home.

























The 13.5 lb Freedom™ portable driver and the 418-lb
“Big Blue” hospital driver for powering the SynCardia
temporary Total Artificial Heart.


CAUTION – The Freedom™ driver system is an investigational device, limited by United States law to investigational use.

About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.


Source:
SynCardia Systems Inc

top

03-02-2010:  Total Artificial Heart Chairman Keynote Speaker at Medical Devices Summit 2010 at Medical Devices Summit 2010

DR. MARVIN SLEPIAN GIVES KEYNOTE SPEECH ON SYNCARDIA'S TOTAL ARTIFICIAL HEART AT MEDICAL DEVICES SUMMIT 2010
SynCardia Chairman Addresses Winning FDA Approval & Medicare Reimbursement for the World’s Only Approved Total Artificial Heart
http://www.syncardia.com


Tucson AZ USA -- Medical Industry E-Mail News™ -- March 02 2010 -- On March 2, Dr. Marvin Slepian, world-renowned interventional cardiologist and co-founder and chairman of SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, was the keynote speaker at the Medical Devices Summit 2010 held in Boston. The conference highlighted key strategies for regulatory compliance, including the latest tips for streamlining the medical device approval process.

“In 2004, SynCardia’s Total Artificial Heart became the first and only Total Artificial Heart in the world to receive Pre-Market Approval from the FDA,” said Dr. Slepian. “In 2008, SynCardia also successfully petitioned the Centers for Medicare & Medicaid Services to reverse its 1986 national non-coverage policy for artificial hearts and approve reimbursement through the highest paying Diagnostic Related Group codes.”

In addition to discussing the development and clinical use of the Total Artificial Heart, Dr. Slepian also addressed the future of SynCardia technologies currently under development, including its new family of pneumatic drivers for powering the Total Artificial Heart and the smaller 50cc Total Artificial Heart designed for women and patients of smaller stature.

Dr. Slepian is Professor of Medicine (Cardiology), Director of Interventional Cardiology and Director of the Tissue Engineering Lab at the University of Arizona. He has founded numerous medical device companies and has served as acting CEO and Board Member of several medical device startups. Additionally, Dr. Slepian has conducted extensive research, development and pre-clinical investigation of novel cardiovascular therapeutic methods and devices, and is the holder of more than 25 issued and 41 filed patents.


SOURCE:
SynCardia Systems Inc


top